Senior Vaccine QA Specialist
EVA Pharma
Posted on 16 Dec
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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.
Desired Candidate Profile
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.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Senior Vaccine QA Specialist
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EVA Pharma
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members. Job Summary/strong>
We are seeking an experienced and highly skilled Senior Vaccine Quality Assurance Specialist/strong> to join our team./p>