Executive - Quality Assurance

Job Overview

The role involves ensuring that pharmaceutical products are produced, tested, and released adhering to regulatory requirements, company policies, and Good Manufacturing Practices (GMP) to assure quality, safety, and effectiveness.

Primary Responsibilities

• Maintain strict compliance with GMP, standard operating procedures (SOPs), and regulatory bodies such as NAFDAC, WHO, and FDA when relevant.
• Supervise production and packaging workflows to confirm adherence to approved protocols.
• Engage actively in both internal and external audits and inspections conducted by regulatory authorities.
• Review and validate batch manufacturing and packaging records and other quality-related documents for accuracy.
• Enforce good documentation practices (GDP) throughout departments and manage SOPs, specifications, and quality records.
• Conduct line clearances before and after production tasks and perform in-process quality checks ensuring compliance with defined quality criteria.
• Oversee environmental condition monitoring as required during manufacturing processes.

Qualifications and Skills

• Bachelor's degree in Pharmacy, Microbiology, Biochemistry, Chemistry, or related scientific fields.
• Professional affiliation or certification such as NIPR or similar regulatory bodies is advantageous.
• Between five to eight years of experience within pharmaceutical manufacturing environments.
• Comprehensive understanding of GMP, GDP, and regulatory standards (NAFDAC, WHO guidelines).
• Experience managing documentation reviews, handling deviations, overseeing Corrective and Preventive Actions (CAPA), and participating in audit processes.
• Skillful use of Microsoft Office suite including Excel, Word, and PowerPoint.
• Awareness of quality management systems, risk assessment, and validation methodologies.