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Director Quality Assurance

As a Director in the PDQA team you provide leadership to the PDQA QP Team and actively contribute to the quality oversight of the Jazz product development pipeline through clinical phases from a science-led, risk based and patient centric approach. Promote a product understanding and risk-based approach to Pharmaceutical Development activities, ensuring that Quality Risk Assessments are performed and documented, identifying appropriate Critical Quality Attributes and Critical Process Parameters.

KBSkills

ACTIVE

If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit<a href="https://www.jazzpharmaceuticals.com" rel="nofollow">www.jazzpharmaceuticals.com</a>for more information.<div>Brief Description:As a Director in the PDQA team you provide leadership to the PDQA QP Team and actively contribute to the quality oversight of the Jazz product development pipeline through clinical phases from a science-led, risk based and patient centric approach.This position is responsible for the management of the day-to-day quality activities relating to pharmaceutical development and providing technical support in relation to issues that can arise with Jazz development products, contract manufacturing organizations and material suppliers, to all applicable GxP standards.  This role also includes cross-functional team membership/collaboration and support for quality aspects of CMC regulatory dossiers.The position reports to the Head of Drug Discovery and Pharmaceutical Development Quality. Essential Functions<ul><li>Act as a Qualified Person (QP) named on the Jazz Dublin MIA IMP.</li><li>Lead the PDQA QP Team at Jazz Pharmaceuticals.</li><li>Act as a PDQA representative on CMC product teams for assigned development projects.</li><li>Ensure that the PDQA QP team provides appropriate support to the CMC matrix teams within Jazz Pharmaceuticals, ensuring that Phase Appropriate GMP is followed throughout the drug development process.</li><li>Provide ‘Quality’ advice on technical issues that may arise for both small or large molecule development projects.</li><li>Ensure the implementation of appropriate global Quality oversight, through Phase I - IV clinical phases of pharmaceutical development.</li><li>Develop and initiate efforts designed to constantly improve and harmonize global processes and systems within PDQA.</li><li>Work closely with the Clinical Trial Management Supply Team to ensure supply of clinical trial material to clinical development programmes.</li><li>Interpret, communicate and implement changes in GMP, ICH and compliance related regulations, standards and practices, as related to pharmaceutical development.</li><li>Promote a product understanding and risk-based approach to Pharmaceutical Development activities, ensuring that Quality Risk Assessments are performed and documented, identifying appropriate Critical Quality Attributes and Critical Process Parameters.</li><li>Provide information and attend, when required, key meetings, such as Quality Management Review, Specifications committee, Pharmaceutical Development Review Committee and the Supplier Review Board, in the context of pharmaceutical development.</li><li>Provide Quality review of CMC regulatory submissions, when required.</li><li>Contribute and provide SME quality support for the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required.</li><li>Act as lead auditor in third party vendor audits for IMPs, to include: GMP contract manufacturing, analytical testing and storage facilities when required to ensure compliance with Jazz requirements and country specific regulations.</li><li>Ensure compliance of all contract manufacturers to both internal Jazz requirements and country specific regulations.  To include person-in-plant support, when required.</li><li>Prepare and/or act as an SME for Quality Technical Agreements within the PDQA Team</li><li>Facilitate Technology Transfer, process scale-up and process improvement projects i.e. assisting with the transitioning of Jazz development products from the Investigational Medicinal Product space to Commercial Product space.</li><li>Work closely with other members of the Technical Operations group to ensure delivery of key project objectives and timelines.</li><li>Responsible for the successful, timely completion of goals and objectives within PDQA.</li></ul>Required Knowledge, Skills, and Abilities <ul><li>10+ years of practical experience in the Pharmaceutical Industry in QA or QC role(s) with a thorough understanding of GMP and Quality Systems, as they related to product development.</li><li>Ideally have significant experience (5-10 years) working in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms and finished pharmaceutical products.</li><li>Ideally have significant experience working in pharmaceutical development quality.</li><li>Proven track record of leadership and managing quality in a global organization.</li><li>Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms.</li><li>Experience working with contract manufacturing organizations.</li><li>Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs and regulatory documents.</li><li>Experience interfacing with regulatory bodies and working on regulatory submissions.</li><li>Good technical and QA background, having a good understanding of analytical method development and validation and specification setting.</li><li>Extensive experience in GxP regulatory compliance requirements, as they relate to early and late phase pharmaceutical development.</li><li>Knowledge of US and EU GMP guidelines and their implementation for CMC product development.</li><li>Ability to effectively lead and participate on multi-disciplinary teams.</li><li>Ability to work independently with minimal direction.</li><li>Ability to develop and manage a high-performance team driving a positive, inclusive and collaborative culture, in-line with Jazz Values.</li><li>Highly organized, with good time management and the ability to prioritize.</li><li>Critical thinker with the ability to evaluate complex problems.</li><li>Excellent verbal and written communication skills.</li><li>Strong work ethic with a flexible and adaptable approach.</li><li>Careful attention to detail.</li><li>Interpersonal skills and professional skills to interact at all levels, including senior executives, contractors, and colleagues.</li></ul>Required/Preferred Education and Licenses<ul><li>Bachelor’s degree in chemistry, biology, pharmacy or a related discipline.</li><li>Eligibility to act as a licensed Qualified Person</li></ul></div>Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: <a href="https://careers.jazzpharma.com/benefits.html" rel="nofollow">https://careers.jazzpharma.com/benefits.html</a>.--s-p-m1--By applying, you consent to your information being transmitted by Monster to the Employer, as data controller, through the Employer’s data processor SonicJobs. See Jazz Pharma Privacy Policy at https://www.icims.com/legal/privacy-notice-website/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions

Jazz Pharmaceuticals

Director, Pharmaceutical Development QA (Remote/Home Based)

Analytical Method Development

Analytical Method Validation

Auditing

Biology

Biotech and Pharmaceutical

Cancer

Chemistry

Clinical Trial

Clinical Trial Management

Communication Skills

Contract Analysis

Contract Manufacturing

Cross-Functional

Current Good Manufacturing Practice (cGMP)

Detail Oriented

Disease

Documentation

Dosage Forms

Drug Development

Drug Discovery

Establish Priorities

GMP (Good Manufacturing Practices)

ICH Regulations

Insurance

Interpersonal Skills

Jazz

Laboratory

Leadership

Maintain Compliance

Manufacturing

Manufacturing Analysis

Manufacturing/Industrial Processes

Medical Products

Neuroscience

Oncology

Organizational Skills

Pharmacy

Presentation/Verbal Skills

Process Improvement

Product Development

Promotional Programs

Quality Assurance

Quality Control

Quality Management

Regulations

Regulatory Compliance

Regulatory Requirements

Regulatory Submissions

Research & Development (R&D)

Research Laboratory

Risk

Risk Analysis

Sales Pipeline

Sleep Disorders

Small Molecules

Standard Operating Procedures (SOP)

Team Player

Technical Operations

Technical Support

Time Management

Vendor/Supplier Evaluation

Writing Skills

SonicJobs

Quality Assurance Specialist

Responsible for, but not limited to: Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and can identify viable and often innovative options.

If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit<a href="https://www.jazzpharmaceuticals.com" rel="nofollow">www.jazzpharmaceuticals.com</a>for more information.<div>The Biologics Drug Substance Quality Assurance Specialist is Responsible for performing key Quality tasks in respect of Company products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Associate Director of External Manufacturing Quality AssuranceEssential Functions/ResponsibilitiesThe position is responsible for monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards. Responsible for, but not limited to:<ul><li>Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations.</li><li>CMO Batch file review and associated lot Disposition activity.</li><li>Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations</li><li>Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.</li><li>Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required.</li><li>Highlighting any risks associated with maintaining supply of commercial drug products to all markets.</li><li>Conducting vendor audits and vendor site visits as required.</li><li>Assisting in internal audits and regulatory agency inspections.</li><li>Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions</li><li>Assist with the generation of Jazz APQR (Annual Product Quality Review). </li><li>Maintaining product related Quality Technical Agreements (QTAs).</li><li>Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate.</li><li>Review and approve moderated complexity deviations and associated corrective actions.</li><li>Review and approve less complex validation documents.</li><li>Support the generation of new, as well as improvement of, existing department SOPs. </li><li>Support delivery of projects. </li><li>Work with management to resolve project issues and resource constraints within the team. </li><li>Liaise with the internal and external stakeholders to resolve and clarify any point of issue. </li><li>Review and approve executed batch records and product testing records.</li><li>Disposition lots.</li><li>Review and approve moderated complexity deviations and associated corrective actions.</li><li>Review and approve less complex validation documents.</li><li>Partner with other departments/groups to problem-solve and address moderately complex issues.</li><li>Collaborate in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation.</li><li>Represent QA in cross-functional project teams for moderately difficult projects.</li><li>Participate in and facilitate regulatory inspection readiness.</li><li>Coordinates and collaborates with other teams to meet organizational goals and work requirements.</li><li>Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.</li><li>Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.</li><li>Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and can identify viable and often innovative options.</li><li>Uses analytical skills and judgment to recommend the "best" solution.</li><li>Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.</li><li>Maintain quality from cell banking through to production and post-release events (e.g., stability, product complaints).</li></ul>Required Knowledge, Skills, and Abilities <ul><li>Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry.</li><li>Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of biologics drug substance manufacturing.</li><li>Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.</li><li>Experience with contract manufacturing is desirable.</li><li>Significant experience (>5years) of commercial and/or late state clinical phase GMP manufacturing of biologics drug substance products</li><li>Highly organized, with exceptional time management and prioritization.</li><li>Excellent verbal and written communication skills.</li></ul>Required/Preferred Education and Licenses<ul><li>Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline</li></ul></div>Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: <a href="https://careers.jazzpharma.com/benefits.html" rel="nofollow">https://careers.jazzpharma.com/benefits.html</a>.--s-p-m1--By applying, you consent to your information being transmitted by Monster to the Employer, as data controller, through the Employer’s data processor SonicJobs. See Jazz Pharma Privacy Policy at https://www.icims.com/legal/privacy-notice-website/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions

Senior Quality Assurance Specialist (Drug Substance) (Remote/Home Based)

Analysis Skills

Banking Services

Biochemistry

Change Control

Continuous Improvement

Corrective Action

Drug Manufacturing

Drug Products

Identify Issues

Internal Audit

Manufacturing Operations

Microbiology

Moderating Skills

Operations

Operations Processes

Problem Solving Skills

Procedure Implementation

Product Reviews

Product Testing

Quality Assurance Methodology

Test Lab

Testing

Validation Documentation

Validation Plan

location_0_addressRegionName

ONSITE

PERMANENT

FULL_TIME

Chemist

This an opportunity for you to undertake training to broaden your knowledge of biopharmaceutical analysis and analytical techniques, whilst thriving in a supportive environment where you can grow and develop into a leadership role. Science is about integrity, tenacity, and possibility - and this job opportunity is a platform for the exploratory journey that you, an experienced Analytical Chemist relish and thrive on.

<img height="1" src="https://counter.adcourier.com/ZmZhcnJlbGwuMzMzNjAuNDc5QGZycy5hcGxpdHJhay5jb20.gif" width="1"/> Analytical Chemist Science is about integrity, tenacity, and possibility - and this job opportunity is a platform for the exploratory journey that you, an experienced Analytical Chemist relish and thrive on. Because this isn't your typical pigeon-hole, lab-based role; it's a key driving force for this well - respected pharma company's technical future. It's an opportunity to escalate your career and go on to establish yourself as a Analytical Chemistry specialist across the biopharma industry You will be involved in HPLC, GC, CE electrophoresis (SDS-PAGE, IEF and Capillary) Method Validation & Method Development. This an opportunity for you to undertake training to broaden your knowledge of biopharmaceutical analysis and analytical techniques, whilst thriving in a supportive environment where you can grow and develop into a leadership role. Do you offer….? <ul><li>A Chemistry/Biochemistry or Biotechnology Degree?</li><li>3-4 years GMP (essential) industry experience</li><li>Good knowledge and understanding of chromatography techniques?</li></ul> Benefits... <ul><li>Developmental opportunities and career progression</li><li>Private Medical Insurance</li><li>Contributory Pension</li><li>Income protection and life assurance</li><li>Annual bonus</li><li>Free parking onsite</li><li>Additional annual leave days with continued service</li><li>Work-life balance</li><li>Sports and Social Events</li><li>Educational Assistance</li></ul> Interested…? Click apply, submitting an up-to-date CV tailored to this job opportunity and if your experience is deemed suitable I will call you immediately to discuss this Analytical Chemist job . I look forward to hearing from you.

FRS Recruitment

Bioanalytical Chemist

Analytical Chemistry

Chromatography

Health Insurance

High Performance Liquid Chromatography (HPLC)

Life Insurance

Sports

monster

Laboratory Analyst

Other job titles you may have searched for: Laboratory Analyst /Technician Job Limerick, Lab Technician Job Clare, Microbiology Lab Technician job Tipperary , QC microbiologist. Ensure facilities, processes, personnel and materials/products are microbiologically tested in line with cGMP and procedural requirements.

<img height="1" src="https://counter.adcourier.com/ZmZhcnJlbGwuNTE4NDQuNDc5QGZycy5hcGxpdHJhay5jb20.gif" width="1"/> Are you a Microbiology graduate with 1+ years GMP lab-based experience? Currently seeking a Microbiology Lab Analyst to join the QC team of a leading Life Science company in Limerick . Duties: <ul><li>Ensure facilities, processes, personnel and materials/products are microbiologically tested in line with cGMP and procedural requirements</li><li>Maintain laboratory metrics</li><li>Compliance with GMP requirements and uphold these standards</li><li>Perform Environmental monitoring </li></ul> Desired Skills and Experience: <ul><li>1-3 years GMP experience in a highly regulated environment</li><li>Degree qualification in a Science discipline</li><li>Experience of working in a Cleanroom area or Microbiology laboratory</li><li>Proficiency in microbiology aseptic techniques and clean room behaviours</li></ul> For more information on this Microbiology Lab Analyst Job please contact Felicity Farrell on 086 7821714 Other job titles you may have searched for: Laboratory Analyst /Technician Job Limerick, Lab Technician Job Clare, Microbiology Lab Technician job Tipperary , QC microbiologist

Microbiology Lab Analyst

Asepsis

Cleanroom

Environmental Monitoring

Laboratory Analysis

Metrics

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Jazz Pharmaceuticals

Jazz Pharmaceuticals

FRS Recruitment

FRS Recruitment