Laboratory Technologist - Quality AssuranceNew!

• Provide QA oversight of quality control laboratory operations and GMP compliance.
• Review and approve laboratory SOPs, specifications, analytical procedures and controlled laboratory documents.
• Verify implementation of approved laboratory procedures.
• Review laboratory records for completeness, traceability and compliance.
• Provide QA oversight of OOS and OOT investigations.
• Review laboratory deviations and related CAPA.
• Review analytical method validation and verification documentation from a QA perspective.
• Provide QA oversight of laboratory equipment qualification and computerized laboratory systems.
• Review laboratory computerized system validation documentation.
• Verify sample traceability from receipt through testing and reporting.
• Review environmental monitoring results and trends from a QA perspective.
• Review critical laboratory quality trends and escalate adverse trends.
• Provide QA input into product release decisions based on laboratory documentation and results.

Qualifications & Experience:

• Bachelor's degree in Pharmacy, Microbiology, Biochemistry, Biomedical Sciences, Chemistry or a related science discipline.
• Hands-on experience in quality assurance, quality control laboratory operations or pharmaceutical laboratory quality systems.
• Strong understanding of GMP, laboratory quality systems, OOS and OOT, deviations, CAPA and change control.
• Knowledge of analytical method validation and verification, equipment qualification and computerized laboratory systems.
• Strong understanding of data integrity principles applicable to laboratory operations.
• Knowledge of European Pharmacopoeia, WHO GMP and ICH guidelines.
• Experience in pharmaceutical, vaccine, biologics or other regulated manufacturing environments.
• Experience supporting GMP audits, regulatory inspections and laboratory investigations.

Skills & Competencies:

• Documentation and review.
• Analytical and problem-solving ability.
• Attention to detail.
• GMP audit readiness.