The QA Specialist will support the QA General Operations team, focusing on quality assurance reviews of manufacturing, QC, and engineering records, as well as handling GMP deviations and approvals of procedures.
Key Responsibilities:
1. Review manufacturing, QC, and engineering documentation and batch records.
2. Address customer complaints and conduct GMP deviation investigations.
3. Author, review, and approve Standard Operating Procedures (SOPs).
4. Perform internal audits to ensure GMP compliance.
5. Participate in cross-functional projects representing QA.
Skills & Qualifications:
1. Experience in the pharmaceutical industry, preferably in QA.
2. Knowledge of cGMP standards (FDA/EMEA).
3. Proficiency in root cause analysis and quality assurance systems.
4. Strong communication and documentation skills.
5. Familiarity with Microsoft Office.
Education & Experience:
Bachelor’s degree with 4+ years in a GMP environment or a Master’s degree with 2+ years of experience.
Terms:
12 Month Contract, Full-time, Mon – Friday
Package:
Negotiable salary
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