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Job Summary
We are seeking an experienced and highly skilled Senior Vaccine Quality Assurance Specialist to join our team.
The ideal candidate will provide advanced QA oversight for vaccine manufacturing processes, ensure full compliance with GMP standards, and support continuous improvement initiatives to maintain excellence in product quality and patient safety.
Responsibilities:
- Provide senior-level QA oversight for all vaccine manufacturing, filling, and packaging operations, ensuring strict adherence to GMP, SOPs, and regulatory requirements.
- Review and approve vaccine batch production records, investigations, protocols, and reports.
- Lead deviation investigations related to vaccine operations and ensure timely and effective CAPA implementation.
- Monitor and evaluate environmental conditions in classified areas, ensuring compliance and escalating any concerning trends.
- Coordinate and support internal audits, regulatory inspections, and external audits related to vaccine processes.
- Participate in change control assessments and risk assessments for vaccine equipment, materials, and processes.
- Provide guidance, training, and support to junior QA specialists and production teams on GMP, data integrity, and documentation standards.
- Identify quality gaps and drive continuous improvement initiatives to enhance vaccine process robustness and compliance.
- Ensure proper documentation practices (GDP) and data integrity (ALCOA+) throughout all vaccine-related activities
Requirements
- Bachelor's degree in Pharmacy (mandatory).
- 3-4 years of experience in pharmaceutical Quality Assurance; vaccine manufacturing experience is strongly preferred.
- Strong knowledge of cGMP, GDP, CAPA systems, change control, and deviation management.
- Experience supporting audits and inspections (FDA, EMA, WHO, or local authorities is a plus).
- Solid understanding of cleanroom controls, aseptic practices, and environmental monitoring requirements.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication skills and ability to collaborate cross-functionally.
- Proven ability to coach and guide junior team members
