Senior Quality Assurance Specialist
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 Senior Quality Assurance Specialist to join our dynamic team.
The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
Key Responsibilities:
- Monitor and oversee environmental conditions (temperature, humidity, and pressure differentials), ensuring consistent compliance with GMP requirements across production and warehouse areas, and provide guidance on any observed trends or deviations.
- Supervise raw material dispensing activities, ensuring adherence to specifications and verifying calculations in line with approved SOPs.
- Provide oversight of manufacturing and packaging operations, ensuring full compliance with GMP, SOPs, and data integrity requirements, while supporting continuous improvement initiatives.
- Review and approve batch records and logbooks, ensuring completeness, accuracy, and compliance with GDP standards.
- Lead the handling of deviations, non-conformities, and incidents, including conducting or supporting root cause investigations and ensuring effective implementation and follow-up of CAPA.
Requirements
- Bachelor's degree in Pharmacy.
- 2-4 years of relevant experience in a pharmaceutical QA environment.
- Strong knowledge of cGMP and GDP principles.
- Solid understanding of CAPA, change control, deviation management, and quality documentation systems.
- Familiarity with ISO 9001, quality systems, and safety programs.
- Good understanding of validation principles and basic statistical concepts.