We are seeking a Quality Assurance (QA) professional with hands-on experience in analytical method validation and strong exposure to Quality Control (QC) operations. The role provides QA oversight and support for analytical validation activities and QC equipment qualification, ensuring compliance with GMP and regulatory requirements.
Key Responsibilities
- Provide QA support and review for analytical method validation execution, including protocols, reports, and deviations.
- Support and review QC equipment qualification activities (IQ/OQ/PQ), where applicable.
- Act as a QA interface with QC laboratories for analytical and equipment-related activities.
- Review and approve validation and QC documentation, ensuring compliance with GMP standards.
- Support deviation, CAPA, and change control related to analytical methods and QC equipment.
- Participate in audit and inspection readiness, including internal and regulatory audits.
- Collaborate with QC, Validation, and Engineering teams to ensure compliant execution of analytical activities.
Requirements
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or related discipline.
- 36 years of experience in a GMP-regulated pharmaceutical or biotech environment.
- Hands-on experience in analytical method validation execution (or prior role within QC).
- Experience in equipment qualification (QC or general) is preferred.
- Good understanding of GMP, validation, and laboratory compliance.
- Strong documentation and communication skills.
