Executive-Quality Control
Shalina Healthcare
Remote
To ensure that all raw materials, in-process products, and finished pharmaceutical products meet the required quality standards in compliance with regulatory guidelines, GMP requirements, and company quality policies.
Key Responsibilities
- Perform routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
- Ensure compliance with Good Manufacturing Practices (GMP), GLP, and regulatory requirements (e.g., NAFDAC, WHO, FDA where applicable).
- Conduct chemical, physical, and instrumental analysis using equipment such as HPLC, GC, UV Spectrophotometer, and dissolution apparatus.
- Review and interpret analytical data and ensure accurate documentation of results.
- Prepare and standardize reagents, solutions, and volumetric standards.
- Maintain laboratory instruments and ensure calibration and validation are carried out as per schedule.
- Participate in method validation, method transfer, and verification activities.
- Investigate Out of Specification (OOS), Out of Trend (OOT), and deviations, and support root cause analysis and CAPA implementation.
- Ensure proper documentation in line with data integrity principles (ALCOA+).
- Maintain laboratory cleanliness and adhere to safety procedures.
- Support internal and external audits, including regulatory inspections.
- Prepare Certificates of Analysis (CoA) and ensure timely release of materials/products.
- Bachelor’s degree in chemistry, Biochemistry, or related field.
- Minimum of 5–8 years’ experience in a pharmaceutical manufacturing environment.
- Strong knowledge of analytical techniques and laboratory instruments.
- Good understanding of GMP, GLP, and regulatory requirements (NAFDAC, WHO).