QA Validation Specialist

2 weeks ago

Cork, Cork, Ireland PM Group Full time

Overview The Outsourced Technical Services (OTS) Department at PM Group partners with Global leaders across a range of industries to find the best people for their current and ongoing business needs. Partnering with PM Group and our clients means that you will gain unrivalled experience working with global brands. We are seeking a skilled and experienced QA Validation Specialist to join a Client Validation team. This role will be responsible for the review and approval of validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment. Responsibilities Provide project management oversight from a Quality perspective for FUE activities related to products and facilities, utilities, equipment (FUE) Assist Functional Validation groups in the development of validation plans for specific system implementation projects Review and Approval of project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the client, validation techniques/approaches and systems utilized at the client site Lead and represent Validation in multi-departmental meetings & project teams Identify and implement improvements to the QA Validation systems Participation in the change control program for NPIs, capital projects and modifications to qualified systems Ensure maintenance of the qualified/validated state within the Revalidation Evaluation and Requalification programmes Review and Approval of validation activities and documentation related to maintenance of qualified / validated states Assess the impact of changes to the validated state of systems/equipment as part of the site change control program (e.g. system implementation projects /system modifications, etc.) and QMS deviations. Demonstrate a robust understanding of Change Control process, appreciating wider implications to site beyond immediate requirement Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks Coordinate validation activities involving cross-functional, multi-departmental teams including: Engineering, Manufacturing, Process Sciences, Quality Control, Quality Assurance, Regulatory Affairs, and others. Qualifications Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required +5 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation Organizational and management skills to coordinate multi-discipline project group Ability to speak, present data, and defend approaches in front of audiences and inspectors Ability to comprehend technical information related to equipment, processes, and regulatory expectations Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations Proficiency with technical summary report review and approval required, with exceptional organizational, spelling, grammar, and typing skills preferred. #LI-AM2

  • QA Validation Associate

    3 weeks ago

    Cork, Cork, Ireland Claran Consultants Ltd Full time

    QA Validation Associate required for a high-performing Biotech facility in Ringaskiddy, Cork, responsible for the review and approval of validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment. Initially a 12...

  • Qa Validation Associate

    13 hours ago

    Cork, Cork, Ireland Claran Consultants Ltd Full time

    QA Validation Associate required for a high-performing Biotech facility in Ringaskiddy, Cork, responsible for the review and approval of validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.Initially a 12...

  • QA Validation Apprentice

    3 weeks ago

    Cork, Cork, Ireland BioMarin Full time

    Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...

  • QA Specialist

    3 days ago

    Cork, Cork, Ireland Recruitment by Aphex Group Full time

    Quality SpecialistPurposeThe Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team.ResponsibilitiesSub System Ownership:Complete sub system ownership responsibilities as per the site System Ownership...

  • Senior Validation Engineer

    5 days ago

    Cork, Cork, Ireland Pm Group Full time

    Company OverviewThe PM Group partners with global leaders to find the best people for their current and ongoing business needs.We are seeking a skilled QA Validation Specialist to join a Client Validation team in a GMP regulated environment.

  • QA Specialist

    4 weeks ago

    Cork, Cork, Ireland CareerWise Recruitment Full time

    Job Description A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.  This is a contract role for a QA Specialist, within the QA Department under the QA packaging and labelling support team. The successful candidate will be required to perform QA...

  • QA Specialist II

    4 weeks ago

    Cork, Cork, Ireland CareerWise Recruitment Full time

    Job Description A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.This role is a QA Specialist II, in the GSIUC QA Department, under the QA General Operations Support team. This specific role is required to perform QA review of manufacturing and...

  • QA Specialist I

    4 weeks ago

    Cork, Cork, Ireland CareerWise Recruitment Full time

    Job Description A QA Specialist I (Packaging and Labelling Operations) is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.This is a contract role for a QA Specialist, within the GSIUC QA Department under the QA packaging and labelling support team. The successful...

  • QA Specialist III

    4 weeks ago

    Cork, Cork, Ireland hays-gcj-v4-pd-online Full time

    Your new company Here in Hays Recruitment, our Multinational Biopharmaceutical client in Cork is hiring a QA Specialist III.The successful candidate will be required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations within the GSIUC QA...

  • QA Specialist

    4 weeks ago

    Cork, Cork, Ireland PE Global Full time

    Position Summary: This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation...

  • Qa Specialist

    6 days ago

    Cork, Cork, Ireland 7566-Janssen Sciences Ireland Unlimited Company Legal Entity Full time

    time left to apply End Date: March 28, days left to apply)job requisition id R-002659At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise...

  • QA Specialist

    1 week ago

    Cork, Cork, Ireland TN Ireland Full time

    Social network you want to login/join with:QA Specialist (QA Materials Test & Release) (QAMTR), CorkClient:Location: Cork, IrelandJob Category: OtherEU work permit required: YesJob Reference: 211dc79b915bJob Views: 2Posted: 20.03.2025Expiry Date: 04.05.2025Job Description:Essential Duties and Job Functions:Participates within inter-departmental and...

  • QA Specialist

    4 weeks ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    QA Specialist RK 3797 Contract – 12 months CorkWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Responsible for managing compliance activities and QA...

  • Validation Quality Assurance Manager

    4 hours ago

    Cork, Cork, Ireland Pm Group Full time

    Job DescriptionPm Group is seeking a skilled and experienced QA Validation Specialist to join a Client Validation team.The successful candidate will be responsible for reviewing and approving validation lifecycle activities in a GMP regulated environment, focused on implementation of new manufacturing processes, equipment, computer systems, laboratory...

  • QA Specialist 12 M

    4 weeks ago

    Cork, Cork, Ireland CareerWise Recruitment Full time

    Job Description A QA Specialist is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational pharmaceutical Company. This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include...

  • QA Specialist

    2 weeks ago

    Cork, Cork, Ireland Catalyx Full time

    Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers.Who We Are:Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully...

  • QA Specialist

    1 day ago

    Cork, Cork, Ireland Catalyx Full time

    Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers.Who We Are:Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully...

  • QA Specialist

    2 weeks ago

    Cork, Cork, Ireland 7566-Janssen Sciences Ireland Unlimited Company Legal Entity Full time

    time left to apply End Date: March 28, 2025 (13 days left to apply)job requisition id R-002659At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through...

  • Senior Specialist QA

    2 weeks ago

    Cork, Cork, Ireland Stryker UK Limited Full time

    Work Flexibility: Hybrid QA Senior Specialist, UK & BNN Group: RAQA Division: EMEA Location: UK/Nordic/Benelux Position Summary Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and...

  • Validation and Compliance Expert

    7 days ago

    Cork, Cork, Ireland Life Science Recruitment Full time

    About the RoleWe are seeking a highly skilled Process Validator to join our client's team. As a key member of the QA Validation team, you will play a crucial role in ensuring compliance with regulations and industry standards.