Vaccine QA Specialist
1 week ago
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
We are seeking a passionate and talented Vaccine Quality Assurance Specialist to join our dynamic team.
The ideal candidate will ensure that all vaccine manufacturing and handling processes meet the highest standards of quality and compliance, supporting our mission to enhance human health and well-being.
Responsibilities:
- Monitor environmental conditions (temperature, humidity, pressure differentials) across vaccine production and storage areas, ensuring compliance with GMP requirements.
- Participate in raw material dispensing for vaccine manufacturing and verify specifications and calculations as per SOPs.
- Oversee vaccine manufacturing and packaging operations to ensure adherence to GMP, SOPs, and data integrity requirements.
- Review batch records and logbooks related to vaccine production for completeness, accuracy, and compliance with GDP.
- Record and report deviations, non-conformities, and incidents specific to vaccine processes. Participate in root cause investigations and track corrective and preventive actions (CAPA).
Requirements
- Bachelor's degree in Pharmacy.
- 0–2 years of relevant experience in pharmaceutical QA; experience in vaccine manufacturing is a plus.
- Knowledge of cGMP and GDP principles.
- Understanding of CAPA, change control, and quality documentation systems.
- Familiarity with ISO 9001 and safety programs.
- Awareness of validation principles and basic statistical concepts.
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