Posted 4 months ago
Senior Quality Assurance Specialist
AI Summary
Senior Quality Assurance Specialist is responsible for ensuring GMP/GDP compliance across manufacturing and packaging operations, reviewing batch records, handling deviations, and driving CAPA and continuous improvement.
About this role
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
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Bachelor's degree in Pharmacy.
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2-4 years of relevant experience in a pharmaceutical QA environment.
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Strong knowledge of cGMP and GDP principles.
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Solid understanding of CAPA, change control, deviation management, and quality documentation systems.
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Familiarity with ISO 9001, quality systems, and safety programs.
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Good understanding of validation principles and basic statistical concepts.
Skills
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