Quality Control Manager

Location: Ilorin, Kwara
Employment Type: Full-time

Description

• The Quality Control (QC) Manager in our Large Volume Parenterals (LVP) infusion company oversees critical laboratory testing, environmental monitoring, and cGMP compliance to ensure sterile IV fluids are safe, pyrogen-free, and fit for patient use. He holds final authority on product release and supplier quality

Key Responsibilities

• Deviations & CAPA: Direct root-cause analyses for Out-of-Specification (OOS) results, manufacturing deviations, and customer complaints. Develop and track Corrective and Preventive Actions (CAPA)
• Audits & Inspections: Act as the primary technical point of contact during regulatory inspections (e.g., NAFDAC, WHO, USFDA) and client audits.
• Product Release & Compliance: Hold absolute authority to approve or reject raw materials, packaging materials, and finished LVP batches based on strict analytical and sterility results
• Sterility & Environmental Control: Manage rigorous testing for particulate matter, bacterial endotoxins, sterility, and container closure integrity. Oversee routine environmental monitoring of aseptic processing areas.
• Laboratory Operations: Oversee all testing functions including chemical, instrumental, and microbiological analysis. Ensure compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP)
• Stability Studies: Design and monitor ongoing and accelerated stability programs to ensure IV products maintain their integrity and potency over their shelf life.
• Team Leadership: Recruit, train, and mentor QC analysts and microbiologists. Manage annual budgets and maintain testing equipment calibration schedules.

Qualifications & Requirements

• Extensive experience in Large Volume Parenterals (LVP)
• Experience: 7 - 10 years of progressive experience in pharmaceutical QC, with at least 3–5 years in a managerial role specifically within sterile manufacturing or parenteral (IV) operations
• Technical Knowledge: Expert-level understanding of pharmacopeia standards (USP, EP, BP) and aseptic processing technologies
• Education: Minimum of a Bachelor’s degree in Pharmacy, Microbiology, Chemistry, or Pharmaceutical Sciences; Master’s or Pharm.D. is highly preferred