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Relocation Specialist
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QA Specialist - Dublin, Ireland - Cpl
Description
Cpl with our client Pfizer is looking for QA Specialist with lab equipment and computer systems validation experience.
Purpose
To effectively guide the implementation of the Site Validation
Activities, working with the engineering, operations and QC teams to oversee the qualification and validation of the computer systems - CSV and lab area.
Job responsibilities
• To review and approve validation/qualification/verification
protocols/reports, procedures, specifications, validation deviations and project validation/plans as required.
• Approval of validation related investigations to ensure timely close-out.
• Review and approval of validation related deviations, change controls, commitments.
• QA oversight on Validation Projects:
Pre and post approval of validation documents i.e. Validation Plans, URS, IOQ, PQ, Vendor Protocols, Summary Reports, Requirements Traceability Matrix, Validation Plans, Requalification documents, Periodic Reviews and SOPs.
• Extensive knowledge in lab equipment and associated software qualification.
• Write or assist in writing of policies, SOPs, work instructions
and forms for validation requirements and other quality systems as necessary.
• Maintenance and archiving of Validation/Qualification documentation.
• Work closely with other departments such as Engineering, QC
Laboratories, Operations, Supply Chain and Process Development to ensure that validation project plans are understood and adhered to.
• Interact with external consultants, suppliers and contractors to ensure successful process and equipment validation.
• Support Regulatory Inspections and third-party audits.
• Maintain understanding of cGMP and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
• Participate in risk assessments to develop process validation plans and protocols with Development, Operations and QC staff.
Desired requirements
• BSc degree in Science / Engineering
• Familiar with data integrity practices and ALCOA principles.
• Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
• Experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation.
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