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Quality Assurance Validation Lead
2 months ago
Position Overview:
In this role, you will report directly to the Head of Quality Assurance and will be pivotal in spearheading the Validation department. Your primary responsibility will be to cultivate a proficient team and elevate the validation capabilities within the organization. This includes overseeing all activities related to manufacturing and laboratory equipment, facility management, utility systems, and computer systems, ensuring compliance with Good Manufacturing Practices (GMP).
Key Responsibilities:
- Lead a dedicated team to establish comprehensive validation master plans (VMPs), protocols, and procedures.
- Develop and uphold validation plans (VPs) while identifying specific validation needs.
- Contribute to the creation of User Requirement Specifications, as well as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Collaborate with external partners and project teams to ensure that specialized validation activities are executed effectively.
- Implement validation protocols for various equipment, facilities, and utilities.
- A degree or equivalent qualification in a scientific discipline.
- Relevant certifications in validation and quality compliance, including GMP, ICH, FDA, USP, and EP standards.
- Proven experience in validating manufacturing and laboratory equipment, facilities, utilities, and processes, along with the generation of lifecycle documentation (URS, DQ, IQ, OQ, & PQ) in the biopharmaceutical sector.
- Extensive experience in leading validation initiatives within the biopharmaceutical or Advanced Therapy Medicinal Products (ATMP) industries.
- Strong understanding and hands-on experience with aseptic processing and cleanroom technologies.
- A demonstrated history of successfully establishing validation master plans (VMPs).
