A key role has become available for a QA Validation Specialist to join the thriving Cregg Group in 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:
Maintain and archive validation/qualification documentation. Ensure validation project plans are understood and adhered to by collaborating with other departments such as Engineering, QC Laboratories, Operations, Supply Chain, and Process Development.
Review and Approval of Validation Documents:
Review and approve validation, qualification protocols and reports. Maintain knowledge of cGMP, Good Engineering Practices, and guidance in relation to all aspects of validation across manufacturing, laboratories, and facilities.
Data Integrity and Compliance:
Support data integrity compliance activities across the site. Provide QA support for the generation of Process and QC Equipment Installation, Operational and Performance Qualifications, review and approval of the Qualification protocols, discrepancies, and reports for Quality.
Personal Accountability:
Ensure own training is undertaken in a timely and GMP compliant manner before undertaking tasks. Ensure any GMP documentation assigned (e.g., Issues, CAPAs, Change Controls, BMRs & audit/inspection actions) are closed in a timely and satisfactory state.
Validation and Regulatory Requirements:
Ensure validation of processes and equipment meets applicable regulatory requirements. Guide the implementation of the Site Validation Master Plan, working with engineering, operations, and QC teams to oversee the commissioning; qualification, and validation of the manufacturing facility and supporting activities.
Key Requirements
Educational Background:
Level 8 Degree in Science or Engineering.
Professional Experience:
Proven track record in delivering robust and regulatory compliant validation plans and protocols. Strong quality assurance background in pharmaceutical or biotech production within sterile manufacturing. GMP and GXP experience is essential.
Skill Set:
Excellent communication and interpersonal skills, with fluent English. Extensive experience with providing QA technical support and oversight to validation and qualification activities, including computer system validation. Familiarity with EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11, and ICH Q9.