Executive - Quality Control at Shalina Healthcare

Job Purpose

• 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.

Qualifications & Experience

• Bachelor’s Degree in Chemistry, Biochemistry, or related field.
• 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).