quality manager jobs

Near clare
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2 jobs found for quality manager jobs Near clare

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Packaging Team Leader/Manager

Aerie Pharmaceuticals

Ireland, We
25 days ago
Ireland, We
25 days ago
 
The Packaging Team Leader leads Aerie’s secondary packaging operations in Athlone through the completion of secondary packaging manufacturing activity.
 
Packaging operations involve high speed packaging of sterile eye drop bottles including brite stock packaging, finished packaging include labelling, cartoning, bundling, case packing and palletisation. The packaging team leader is also responsible for the resulting manufacturing batch records used to record manufacturing activity and to enable the release of product batches to the market.

Essential Duties, Functions and Responsibilities:
  • Works with manufacturing and quality colleagues as part of an Operation’s team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety personally and within the team to ensure a safety first culture when operating equipment within packaging – champions safe working always.
  • Ensures focus on the quality performance of the packaging area to ensure system and human errors are minimised through SOP and MBR design and through daily focus on quality culture.
    • Leads the packaging area and the manufacture of products in accordance with the production schedule, BOMs and finished product specifications.
    • Coordinates manufacturing activity according to schedules agreed with Supply Chain and ensure engagement of support areas required to assist in packaging performance.
    • Monitors and reports on key area performance metrics across safety, quality, delivery and cost.
    • Leads the recruitment, training and performance management of the members of the Packaging manufacturing team.
    • Leads the packaging area in nurturing a continuous improvement culture and the deployment of appropriate lean ways of working to enable that continuous improve drive.
  • Lead Packaging Operations on the site’s New Product Introduction team.
    • Represent Packaging Operations as the manufacturing SME at regulatory audits and lead the area in preparing for these audits.
    • Provides manufacturing support for product PPRs (Periodic Product Review) from a Packaging perspective.
  • Ensures effective manufacturing investigation into deviations and process/equipment downtime.
  • Supports validation activity as required.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Skills/Knowledge Required: 
  • Strong knowledge of finished product packaging operations and track record leading in a high volume regulated environment.
    • Understanding of pharmaceutical industry regulatory requirements as they apply to packaging.
    • Strong leader of operations personnel with direct supervision experience.
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams.
    • Strong team player with proactive approach & manner.
Education Required:
  • Bachelor’s Degree in Science/Manufacturing/Engineering or equivalent.
Experience Required:
  • 5+ years relevant experience in a pharmaceutical manufacturing or similar environment with at least 3+ in a supervision/leadership capacity.
  • Demonstrated experience in managing the day-to-day activities of a packaging/manufacturing team.
  • Skilled at motivating a multifunctional team to achieve organizational goals.
  • Comfortable developing and implementing a timeline to achieve targets.
  • Demonstrated experience in managing performance, delegating tasks and coaching and training team members to maximize their potential.
 
E
E

Senior Manager - Quality Laboratory

Edwards Lifesciences

Shannon
24 days ago
Shannon
24 days ago
The Company:
Edwards Lifesciences is driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
The Role:
Provide leadership and management of the site laboratories (e.g., Microbiology, Chemistry) including sterility assurance, production support and environmental monitoring in support of production operation.
Key Responsibilities:
• Manage a team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities for the development, validation and implementation of laboratory test methods to support production, new product transfers, and product release activities. Responsible for site laboratory budget, and assessing, improving, and ensuring laboratory equipment, methods and systems meet quality and regulatory requirements. Ensure staff have appropriate education, training, and experience to perform assigned responsibilities. Drive a culture that is focused on quality and business results. Create an environment that fosters employee motivation and engagement.
• Lead in identifying risk, developing mitigation strategies, defining alternative solutions, and resolving issues in collaboration with cross functional groups.
• Responsible for providing subject matter expertise and technical support on product and process investigations.
• Develop robust talent development plan in alignment with functional growth strategies of the department.
• Responsible for ensuring laboratory specific investigations are performed in compliance with quality and regulatory requirements.
• Lead efforts to optimize laboratory processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
• Actively participate in the EW Global Laboratory council to help drive consistency and improvement and lead initiatives across laboratory network.
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related scientific field (e.g., chemistry, biology or microbiology)related experience within applicable regulated laboratory required and skill levels exceeding the requirements of the previous level
Experience in Quality and/or Compliance management in the medical device, pharmaceutical industry, or the equivalent
Demonstrated track record in effective laboratory management, including compliance, technical excellence, and organizational development Required
Additional Skills:
• Proven successful project management leadership skills
• Proven expertise in both Microsoft Office Suite and related systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of quality laboratory and technical procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of related aspects of quality laboratory processes and/or systems
• Expert knowledge of FDA Quality System Regulations, Good Laboratory Practices (GLP) and ISO/EN standards
• Knowledge of financial acumen as it relates to the business as well as quality laboratories
• Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality laboratories to the business
• Serve as core partner to senior leaders in Business Units, Functional Groups, and Regions
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Travel Requirements:
10 % International
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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Posted

25 days ago

Description

 
The Packaging Team Leader leads Aerie’s secondary packaging operations in Athlone through the completion of secondary packaging manufacturing activity.
 
Packaging operations involve high speed packaging of sterile eye drop bottles including brite stock packaging, finished packaging include labelling, cartoning, bundling, case packing and palletisation. The packaging team leader is also responsible for the resulting manufacturing batch records used to record manufacturing activity and to enable the release of product batches to the market.

Essential Duties, Functions and Responsibilities:
  • Works with manufacturing and quality colleagues as part of an Operation’s team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety personally and within the team to ensure a safety first culture when operating equipment within packaging – champions safe working always.
  • Ensures focus on the quality performance of the packaging area to ensure system and human errors are minimised through SOP and MBR design and through daily focus on quality culture.
    • Leads the packaging area and the manufacture of products in accordance with the production schedule, BOMs and finished product specifications.
    • Coordinates manufacturing activity according to schedules agreed with Supply Chain and ensure engagement of support areas required to assist in packaging performance.
    • Monitors and reports on key area performance metrics across safety, quality, delivery and cost.
    • Leads the recruitment, training and performance management of the members of the Packaging manufacturing team.
    • Leads the packaging area in nurturing a continuous improvement culture and the deployment of appropriate lean ways of working to enable that continuous improve drive.
  • Lead Packaging Operations on the site’s New Product Introduction team.
    • Represent Packaging Operations as the manufacturing SME at regulatory audits and lead the area in preparing for these audits.
    • Provides manufacturing support for product PPRs (Periodic Product Review) from a Packaging perspective.
  • Ensures effective manufacturing investigation into deviations and process/equipment downtime.
  • Supports validation activity as required.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.


Skills/Knowledge Required: 
  • Strong knowledge of finished product packaging operations and track record leading in a high volume regulated environment.
    • Understanding of pharmaceutical industry regulatory requirements as they apply to packaging.
    • Strong leader of operations personnel with direct supervision experience.
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams.
    • Strong team player with proactive approach & manner.
Education Required:
  • Bachelor’s Degree in Science/Manufacturing/Engineering or equivalent.
Experience Required:
  • 5+ years relevant experience in a pharmaceutical manufacturing or similar environment with at least 3+ in a supervision/leadership capacity.
  • Demonstrated experience in managing the day-to-day activities of a packaging/manufacturing team.
  • Skilled at motivating a multifunctional team to achieve organizational goals.
  • Comfortable developing and implementing a timeline to achieve targets.
  • Demonstrated experience in managing performance, delegating tasks and coaching and training team members to maximize their potential.
 
Source: Aerie Pharmaceuticals