Summary:
An External Quality Specialist is required for a pharmaceutical in South Tipperary. The successful candidate will be responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with expectations and all applicable regulatory requirements. Incumbent will have responsibility for External Party / External Partner (EP/ExP) operations related to the quality of products produced, under the oversight and guidance of the Product Quality Manager Lead – EQA. Role has primary batch release responsibility. Incumbent will ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the EP/ExP’s manufacture. This is a remote role and the candidate can be located anywhere in the Republic of Ireland.

Responsibilities:

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records.
• Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.
• Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
• Provide support for audits of EP/ExP and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
• Support routine analytical change requests and support process modification change controls.
• Annual Product Review assembly.
• Support document requests for regulatory filings and post approval changes.
• Gap remediation plans, Quality Risk Management data inputs, and data integrity gap assessments.
• Receive and share Quality Alerts and Quality Bulletins with EP/ExP.
• Closely collaborate with appropriate business/operations and technical areas to achieve objectives.
• Ensure both operational knowledge and technical skills are maintained and compliant against individual training requirements.

Qualifications & Experience:

• B.Sc. Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
• Minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute Merck/MSD product.
• Experience in SAP and Trackwise.
• Thorough knowledge of all aspects of EM management, supply chain, and operations.
• A broad knowledge of manufacturing operations, including engineering, materials, R&D, production, etc.
• Lean Six Sigma Production Systems training.
• Ability to work across boundaries.
• Strong problem-solving skills.
• Effective written and oral communication skills.
• Proactive and self-motivated, well developed organizational skills with ability to multitask.
• Strong interpersonal and relationship building skills; effective negotiation and influence skills.

Content Specialist - EMEA
Cork

Working for a multination networking company who are looking to hire a Digital Content Specialist to support their EMEA Brand online.

Ensure product content is always up to date, new product information is posted on time, ensure consistency across all countries across EMEA and grown profit and sales volume for the company. The role is a combination of project manager and digital design, production and SEO optimization.

Duties include:
• Project manage execution of all New Product Introductions (NPI) across EMEA - both consumer and business-to-business solutions.
• Project manage and produce all digital content projects across EMEA - plan, track and execute these deliverables on a daily basis.
• Work with each country account manager to ensure local language accuracy, responsible for ongoing SEO and product page variation updates.
• Develop content, assist with localisation of, and manage execution of product page content for EMEA-specific products where content has not originated in the US.
• Update and maintain brand stores across Europe
• Design and develop creative assets for Search and Display advertising.

Skills/Qualifications:
• Highly proficient in Adobe Photoshop, Illustrator
• 3+ years’ experience in editing photography/typography/illustration
• 3+ years’ experience project managing a high volume of marketing tactics, with the ability to provide daily, up-to-date status on any given project
• Experience with editing videos ideal but not essential
• Background in light technical writing, marketing would also be ideal but not essential

Please email your CV to modriscoll@sigmar.ie or call Marie on 021-4847133 to discuss the role in further detail.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

Who We Are

At Indeemo, we believe that great things happen when people really understand each other. We are a diverse, agile, human technology company that works with the world's leading brands and market research agencies to help them undertake qualitative research more efficiently. Our Mobile Ethnography platform blends Mobile, Private Social Networking Video to help companies better understand their customers and improve their customer experience.

Our mission is to improve our clients research and design with rich, raw, contextual, human experiences. 

For more on our product, check out this link - https://youtu.be/6DLaxhrosHI

Who You Are

A motivated, savvy, and creative thinking QA Tester looking for both opportunity and challenge as our team experiences rapid growth. The ideal candidate will have the ability to use logic and reasoning and thrive in a fast-paced environment - working collaboratively cross team, but in particular with our development team. 

If youre someone who relishes the grind and is looking to build a career, wed love to hear from you.

Your Day to Day

• Estimate, prioritize, plan and coordinate quality testing activities of all our software: Backend, Front end Mobile apps.
• Maintain and execute test cases and/or regression test suites, manually in support of our daily deployment.
• Test software at the various phases of the development life cycle, including post release tests.
• Production Support and patch/hot-fix management, creating and executing tests to validate issues and fixes.
• Report bugs, and update and track issues through to resolution using Jira and in a manner that ensures that all stakeholders are in a position to reproduce the bug, if required.
• Communicate test results and findings i.e., test sessions, including bugs and producing training documentation, to improve knowledge transfer. 
• Audit current products and identify deficiencies and opportunities.
• Work closely with the overall development team, including Product UX to define opportunities to improve our web portals and mobile applications.

What Youll Need to Excel in this Role

• Bachelor of computer science, engineering or software degree required 
• 3 + years of experience with a variety of different testing techniques such as UI Testing, Test Driven Development Strategies, and others
• Manual test experience required
• Strong knowledge of testing some or all of the following: web-based applications as well as mobile and backend API
• Familiar with tools such as: JIRA, BitBucket, Postman
• Ability to write clear and concise technical documentation
• Strong understanding of the full SDLC
• Experience with writing SQL queries (Selects, Joins etc.)
• Some knowledge of CI/CD tooling and processes an advantage
• A strong knowledge and awareness of the security aspects of software
• Strong and clear verbal and written communication skills are essential patience and the ability to break down technical jargon is key to the user experience
• A continuous learning mindset to keep abreast of new solutions, technologies, and skills

Life at Indeemo

This is not your typical 9 5, there is limitless opportunity here for the right candidate. If you enjoy continuous learning, developing as an individual, and can adapt in a fast-moving technology and customer centric environment, then this role will quickly grow with you.

We believe that good ideas can come from anyone. Our leadership team is committed to fostering a creative and open-door (currently virtual) environment, where everyone is treated with respect, and employees have the opportunity to realize their true potential. 

Aside from a competitive salary, youll have the opportunity to join a world class team with an amazing culture and team spirit. We offer flexible working - combining the best of working at home, with time at our office in Cork. 

If you think this position would be a good fit click Apply Now, we look forward to hearing from you. 

Job Description:

The RPA Architect will be part of the Cloudera Integrations & Applications group. The primary responsibilities of this role will be to design, develop and implement RPA solutions for SaaS & On-Prem applications which includes but not limited to Salesforce, Workday, Netsuite, Concur, OpenAir, Xactly, GSuite and LMS systems such as OpenEdX, Leardot & Skytap. The individual will work closely with Business and IT users in gathering requirements, designing and deploying automation solutions.

Responsibilities:

• Gather business requirements on RPA use cases and translate them into functional and technical specifications

• Architect, design, develop and implement RPA solutions using Automation Anywhere (A2019)  to streamline processes and maximize efficiency

• Design, develop & support Cloud Integration solutions using Dell Boomi.

• Collaborate with RPA Center of Excellence on development best practices and code review of the bots

• Participate in training business users on the use of RPA technologies and in automation best practices

• Manage end to end SDLC encompassing process analysis, design, development, system test, UAT and implementation and post production bug fixes

• Work with cross functional teams to perform end to end testing across the transactional systems

Experience:

• Bachelor/master’s in computer science or Associate Degree.

• At least 4+years of diversified experience in automating processes using RPA Technologies as Senior developer/Architect

• Hands-on experience with the robotics automation tool, preferably Automation Anywhere A2019, is required.

• Experience implementing RPA features such as UI Automation, recognition (OCR), image recognition, text analysis, and PDF processing.

• Experience in IQ Bot/Chatbot/Virtual agent is a plus

• Experience developing automations with ERP/CRM applications such as NetSuite, Oracle and SalesForce is a plus

• Experience with any Cloud Integration platform such as Dell boomi, Mulesoft, Workato is a plus.

• Professional experience in programming (including scripting/coding), SQL, HTML, Python, JavaScript and hands on experience with Open API's (REST/SOAP)

• Possess strong interpersonal and teamwork skills with an attitude of collaboration

• Should have excellent communication skills in both written & verbal English and should have worked in a global/multicultural environment

• Strong analytical, critical thinking, and problem-solving skills

Job Description

We are currently hiring a Digital Technical Integration Analyst (MES) to join our team in Little Island, Cork on a specified purpose contract up to 12 months.
We are the concentrate team in PepsiCo (PGCS) working across the Beverage, Nutrition and Snacks categories to deliver concentrate for many of PepsiCo’s mega brands including Gatorade, 7Up and Pepsi. We are at the heart of PepsiCo products, sourcing ingredients to manufacture more than 1,200 recipes for our brands. We are a global organisation, situated in 16 locations across 9 countries offering careers in various functions from Manufacturing, Supply Chain, Procurement, Quality, Finance, R&D, HR and IT. We want team members who can collaborate in our fast paced global organisation and are passionate about creating and delivering much-loved household brands to markets across the world.
Our Information Technology (IT) team is going through an exciting time. PepsiCo is transforming the way we use technology across all areas of the business, and IT act as our partners, advisers and service providers on this journey. Many of our IT roles have an international focus, and support internal clients across multiple countries, helping them to identify, deploy and optimise the technology needed to deliver outstanding results. Do you have a passion for solving business challenges by leveraging technology? If so we could take your talents to a whole new level.
Role Summary:
The role will form part of the Digital Factory Project. Its purpose is to provide technical analytical and infrastructure skills including, ensuring that the overall project solution is delivered according appropriate standards.
Primary Accountabilities:

• Drive the design, development and delivery of key technical elements of the digital factory solution, to include,
  • Infrastructure landscapes to facilitate Production, Testing and Development Environments.
  • Adherence to security standards
  • Development standards.
  • Data base standards and best practices
  • Change control processes and technology
• Develop and validate the Technical design delivered by the project team in conjunction with the delivery lead.
• Participate in the blueprint sessions to ensure that the technical solutions being proposed are aligned with the business functional requirements and PepsiCo technical standards.
• Review Technical specifications developed by the selected vendor to ensure they match the requirements outlined in the functional documents.
• Assist in the configuration of Wonderware MES where possible.
• Manage the delivery of any changes to existing systems (e.g. SAP MII or other middleware) required for digital factory.
• Work with the business in the development of test data to support the testing phases.
• Become an SME on the technical elements of the MES Solution including integration elements.
• Contribute throughout the lifecycle of the project in the population of the project risk and issue log.
• Assist in the development of the cutover strategy & subsequent plan.
• Participate in the development of the project lessons learned post project.
• Work with the software vendor to manage licenses.
• Advise and lead on approach to elements such as code migration and change management tools.

Qualifications/Requirements

Qualifications\\Requirements:
Essential Skills:

• General IT Technical Skills (Strong understanding of System Architectures, Infrastructure, Databases etc.)
• Experience managing application and/or infrastructure development and support e2e including issue resolution, change analysis, design, implementation, test and deployment, etc.
• Experience with development and project management of shop floor and/or integration functionality.
• Knowledge of integration methods for shop floor solutions to other systems (e.g. ERP/Data warehouse systems).
• Strong database development skills.
• Proficient with Microsoft productivity Tools (MS Office, MS Outlook, MS Project, MS Visio)
• IT Experience (Business Analysis, Solution Delivery, Stakeholder Engagement, Test Management, Support, Project Governance, Change Management).
• Good communication skills and an ability to work with (& manage) virtual project teams
• Ability to work under pressure to tight deadlines, with a drive and commitment towards project delivery.
• Solves highly complex problems within their work team.

• Knowledge of Manufacturing Processes (Preferably PGCS processes)
• Familiarity with S88/S95.
• Demonstrated Industry 4.0 experience and results.
• SAP MII Experience
• Experience with Wonderware Skelta BPM, Wonderware MES, Wonderware Recipe Manager.
• Technical skills desirable in some or all of the following technologies:

• Microsoft Technology environments - Windows Server environments; Infrastructure Virtualisation; LAN, SAN, WAN; Data Centres;
• Experience with Wonderware control systems and tools (InTouch, InBatch, InSQL, ArchestrA System Platform).

Job Description

• Work with flexibility within the Calibrations Department and in co-operation with other Departments.
• Liase with the Calibrations Engineer each morning.
• Ensure all company, Site Engineering policies and Calibration procedures are adhered to.
• Ensure that all calibration deviations are handled and escalated as per company, site procedures.
• Ensure the successful calibration of all process, utility and lab equipment.
• Coordinate with the planning departments, area supervisors and service providers to ensure calibrations are scheduled and performed within required intervals and with minimal equipment down time.
• Respond to technical queries related to calibration instrumentation.
• Carry out faultfinding’s and root cause analysis on breakdowns.
• Ensure that all necessary spares and consumables are available and lLiase with Calibrations Engineer when stock needs updating.
• Promote a Lean Maintenance environment.
• Assist in developing and improving new and existing Calibration routines procedures within a cGMP environment.
• Carry out planned/unplanned maintenance on packaging, production and utilities equipment.
• Proactively follow up on re-occurring technical issues.
• Use of the SAP/Neptune system to record in detail Calibrations activities on equipment/utilities in compliance with regulatory & cGMP requirements.
• Execution of work orders as scheduled through the computerized maintenance management system SAP.
• Participate in Safety and Environmental training programmes and initiatives. Adhere to safe working practices as set out by the Safety Statement and other company safety rules.
• Participate fully in any cross-functional training initiatives and mentor Apprentices when required.
• Available to respond to emergency call out’s .
• Develop and maintain a strong working relationship with all the departments’ customers on site.

• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
• Ensure timely completion of all SOP, reading, training and assessment.
• Other duties as required and directed by the Manager, Maintenance or other Officer appointed by the Board of Directors.

• Minimum of an Instrumentation apprenticeship with at least 2 years experience post apprenticeship and or an electrical apprenticeship working in a calibration environment.

• Trades qualification in instrumentation or electrical and instrumentation.
• Can demonstrate at least 3 years post qualification work experience, ideally in a pharmaceutical environment but not necessary.

• Proven track record of high performance & delivering results.
• The determination and drive to sustain current best practices and the ability to identify develop and implement future best practices.
• Interest in continuous improvement.
• Good interpersonal skills.
• Ability to work well independently and as part of a team.
• Capable of efficiently dealing with high pressure break downs.
• Customer service and task focused.
• Good computer skills and CMMS experience (Word, Excel, CMMS software)
• Positive attitude is key to working within the calibration/maintenance department.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type