Kentam Products Limited, a manufacturer and distributor of pharmaceutical and skin care products invites applications for the following positions
cGMP Quality Control Lab Manager
Lead and manage the QC Lab to support all analytical needs and ensure cGMP compliance, Crate, revise, review and approve SOPs, protocols, supporting analytical data and reports associated with method development, method validation, change controls, testing, and release of GMP starting materials, intermediates and APIs, Verification and calibration of Laboratory equipment, Prepare dossiers and data packages for new drug filing/amendments with regulatory bodies, Conduct investigations regarding OOS results, address, and manage deviations related to analytical procedures and provide updates at daily and weekly meetings, Gather metric information for use in continuous improvement of areas of responsibility, Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan
BS or MS in Chemistry, Pharmaceutical or Life Sciences, 10-15 yrs relevant cGMP QC Lab experience with a minimum 5 yrs supervisory role, (No new graduates please), Expertise in cGMPs, analytical method development, transfer and validation and statistical quality control, Very good knowledge of Good Laboratory Practice Systems, Excellent verbal and scientific technical writing skills, Dynamic and energetic personality able to work in a fast paced pharmaceutical environment on a demanding schedule
All interested candidates should send a cover letter, CV and copies of certificates and 3 traceable refs to Human Resource Manager, Kentam Products Limited, P O Box 898, Mzuzu or email Kentam@africa-online.net subject header “QC LAB MANAGER” Closing date is 18th March
