We are seeking a seasoned Quality Assurance Validation Subject Matter Expert (SME) to lead the QA validation function at our sterile injectable GMP manufacturing site. The successful candidate will provide expert guidance and oversight for all aspects of equipment and utility qualification, process and cleaning validation, media fill activities, process validation, computer system validation, and data integrity compliance. This individual will play a key leadership role in ensuring that validation activities meet regulatory expectations, align with internal quality standards, and support efficient, compliant operations.
Key Responsibilities- Serve as the QA functional lead for validation, owning the quality oversight of validation programs for facilities, utilities, equipment, processes, cleaning, and computerized systems.
- Review and approve validation master plans, protocols, reports, and risk assessments to ensure compliance with current GMP regulations, guidance documents, and internal procedures.
- Provide QA oversight for media fill validations, ensuring proper design, execution, and documentation aligned with sterile product manufacturing requirements.
- Lead the QA review and approval of cleaning validation strategies including campaign rationale, worst-case scenarios, acceptance criteria, and continued verification.
- Provide QA guidance during qualification of equipment and utilities (URS, DQ, IQ, OQ, PQ), ensuring appropriate risk-based approach and adherence to applicable standards.
- Oversee QA review and approval of computer system validation (CSV) deliverables in accordance with 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.
- Serve as QA approver and reviewer for periodic reviews and requalification strategies across validation lifecycle elements.
- Champion data integrity across validation documentation, ensuring ALCOA+ principles are followed and integrated into all validation activities.
- Collaborate with cross-functional teams (Engineering, Validation, Manufacturing, IT, QC) to support timely project execution while upholding QA expectations.
- Act as the SME during internal and external inspections (FDA, EMA, customer audits), defending the site's validation and QA oversight practices.
- Identify and implement continuous improvement opportunities in the validation quality system and associated documentation lifecycle.
- Mentor and train QA and validation staff on current validation expectations and regulatory updates.
Qualifications- Bachelor's or advanced degree in life sciences, engineering, or a related field.
- Minimum 8 years of experience in GMP pharmaceutical manufacturing, with strong experience in quality assurance oversight of validation programs.
- Deep understanding of regulatory requirements (21 CFR Parts 210, 211, 11; EU GMP; Annex 1; ICH Q8-Q10; WHO, PIC/S) and industry best practices (GAMP 5).
- Demonstrated expertise in sterile manufacturing validation, particularly aseptic process simulation (media fill), cleaning validation, and facility qualification.
- Hands-on experience with computer system validation and data integrity controls in a GMP environment.
- Proven ability to collaborate effectively in a matrixed environment and influence cross-functional teams.
- Excellent communication, documentation, and problem-solving skills.
- Prior experience representing QA validation during regulatory inspections strongly preferred.
DisclaimerThis description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required. Role Holder may be asked to perform other duties as required
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