QA Validation Specialist Excellent opportunity for a QA Validation Specialist to join a thriving company in Co. Clare.
The QA Validation Specialist will provide QA technical support and oversight to Qualification and Validation activities of the Manufacturing facility and QC Laboratories, ensuring that processes and equipment are appropriately validated and qualified in accordance with applicable Irish, EU and FDA regulations.
Key Responsibilities: Preparation and Maintenance of the site validation plan.
Maintenance and archiving of Validation/Qualification documentation.
Follow up 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.
Review and approve validation, qualification protocols and reports.
Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
Provide QA support to data integrity compliance activities across the site.
Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
Responsible for ensuring that any GMP documentation assigned to me e.g.
(but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
Ensure validation of the processes and equipment meets applicable regulatory requirements To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities.
Implement robust and fit for purpose validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements.
Key Requirements: Level 8 Degree in Science or Engineering.
Excellent communication & interpersonal skills, fluent English is essential Must have a proven track record in delivering robust and regulatory compliant Validation Plans and Protocols.
Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
GMP and GXP experience is essential Extensive 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 e.g.
EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
For further information please contact Loretta Flynn Skills: QA validation GxP GMP validation engineer