Okechukwu Ernest
Quality Assurance Manager
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About
Results-driven Quality Assurance Manager with 8 years of progressive experience in the pharmaceutical industry ensuring compliance with cGMP, GLP, and regulatory standards (NAFDAC, PCN). Skilled in quality systems management, documentation, validation, vendor qualification, deviation management, CAPA implementation and staff training. Adept at leading cross-functional teams to drive continuous improvement, reduce deviations and strengthen regulatory compliance.
Experience
Quality Control Analyst at BIOPHARMA NIGERIA LTD (2019 – 2022)
- Supervise staff and maintain quality control processes, analyze results and give feedback and guidance to the production team under direct supervision.
- Preparation and standardization of volumetric solutions.
- Ensure that raw materials, products or processes are in accordance with specification.
- Ensure that the staff follow the set processes and adhere to the best practices and product quality standards.
- Ensure that routine and non-routine analysis of raw materials and finished products are adequately done.
- Investigate customer complaints regarding quality issues and develop a solution.
- Maintenance of water treatment plant and Reverse Osmosis (RO) Plant.
- Analysis of Raw water, potable water and production water.
- Operate critical laboratory equipment like HPLC, Uv-vis Spectrophotometer, dissolution apparatus, melting point apparatus, DT Apparatus, Friability test Apparatus etc
- Monitor the performance of quality control systems to ensure effectiveness and efficiency.
- Instruct and train staff in quality control and analytical procedures.
- Ensure Standard Operating Procedure in co-ordination with the Manager, Quality Assurance
- Analytical method development and standardization of laboratory test procedures on new and existing products
- Ensure that daily Calibration and verification of Instruments are carried out.
- Assist Quality Assurance Manager in developing analytical methods for new products.
Quality Assurance Manager at BIOPHARMA NIGERIA LTD (2022 – Present)
- Provide strategic leadership for the Quality Assurance department to ensure full compliance with GMP and NAFDAC requirements.
- Establish, implement and continuously improve the Quality Management System (QMS).
- Review and approve SOPs, specifications, protocols, reports, batch manufacturing records (BMR) and batch packaging records (BPR).
- Lead deviation, incident, OOS/OOT investigations and ensure timely and effective CAPA implementation.
- Manage change control processes and perform quality risk assessments for manufacturing and quality-related changes.
- Coordinate and host regulatory inspections, internal audits, and third‑party audits, ensuring successful outcomes.
- Oversee environmental monitoring programs, water systems (PW/RO), sanitation, and hygiene compliance.
- Ensure qualification and validation of equipment, utilities, cleaning processes and manufacturing processes.
- Perform Annual Product Quality Review (APQR) of products
- Drive continuous improvement initiatives to enhance compliance, efficiency and quality culture.
- Train, mentor and supervise QA personnel and cross‑functional teams on GMP and quality standards
Education
MSc in Pharmaceutical Chemistry – University of Nigeria Nsukka (2015 – 2018)
BSc in Pure and Industrial Chemistry – University of Nigeria Nsukka (2007 – 2011)
West African Examination Council (WAEC) – Community Secondary School Itchi (2000 – 2005)
