Quality Control (QC) Specialist – Pharmaceutical Manufacturing
Specialist Search Recruitment · Durban
Job description
About the role
A leading pharmaceutical manufacturing company is seeking a meticulous Quality Control (QC) Specialist to join its laboratory team. The role involves testing raw materials, in‑process samples, packaging components and finished products to ensure compliance with stringent quality, safety, purity and potency standards.
Key responsibilities
- Perform analytical testing of raw materials, packaging components, in‑process samples and finished pharmaceutical products.
- Operate and troubleshoot sophisticated instrumentation such as HPLC, GC and other analytical equipment.
- Conduct environmental monitoring of cleanrooms, water systems and air quality.
- Maintain GMP, GDP and SOP compliance for all laboratory activities.
- Record, review and manage laboratory data using LIMS, ensuring data integrity.
- Prepare and review Certificates of Analysis (CoAs) and related technical documentation.
- Investigate Out‑of‑Specification (OOS) results, deviations and incidents, including root‑cause analysis and corrective actions.
- Perform routine calibration, maintenance and qualification of laboratory equipment.
- Support continuous improvement initiatives and uphold USP, EP and other pharmacopeial standards.
Required profile
- Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Pharmaceutical Sciences or a related life‑science discipline.
- 2–5 years of laboratory experience in a regulated pharmaceutical, medical manufacturing or similar environment.
- Practical experience with analytical techniques and instrumentation.
- Working knowledge of GMP and Good Documentation Practices (GDP).
- Familiarity with pharmacopeial standards such as USP and EP.
- Experience handling OOS investigations and deviation management.
Required skills
- High‑Performance Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Laboratory Information Management Systems (LIMS)
- Environmental monitoring techniques
- Calibration and equipment qualification
- USP and EP pharmacopeial standards
- GMP and GDP compliance
- Out‑of‑Specification (OOS) investigation
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Published 1 month ago
Expires 2 weeks from now
58 views · 0 interested
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Specialist Search Recruitment
Durban