Senior QA Officer – Investigation & Change Control

Job Details

The Senior QA Officer – Investigation & Change Control is the lead investigator for deviations, out-of-specification (OOS) results, and product complaints for a pharmaceutical manufacturing client of Apeiron Consultancy Ltd. The role drives root cause analysis and manages the Change Control system to ensure all product and process changes are thoroughly evaluated for impact on product quality and patient safety. Reports to QA Manager. Department: Quality Assurance. Duty station is Kampala, Uganda. Employment Type: Full-time. Work Hours: 8. Salary: Not Disclosed.

Key Duties and Responsibilities

• Lead investigations into deviations, OOS, and adverse events and facilitate cross-functional investigation teams to identify true root causes.
• Utilize formal investigation tools (e.g., 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis) to prevent recurrence.
• Develop, implement, and follow up on Corrective and Preventive Actions (CAPAs) to ensure timely closure.
• Review and evaluate Change Control requests to assess the potential impact on validated systems and product quality.
• Conduct Quality Risk Management (QRM) exercises (FMEA) to assess the risk level of deviations and change requests.
• Contribute to the Annual Product Quality Review (APQR) by analyzing investigation trends and stability data.
• Evaluate deviations for reportability to regulatory authorities (e.g., MHRA, FDA) and support the reporting process.

Qualifications, Skills and Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or Engineering.
• 5–7 years of experience in a Quality Assurance/Compliance role within pharmaceuticals/biotech, with at least 3 years specifically handling investigations/change control.
• Certified Quality Auditor (CQA) or Six Sigma Green Belt is an advantage.
• Strong logical reasoning and problem-solving abilities.
• Ability to manage conflict and negotiate with production/manufacturing teams.
• Assertiveness in ensuring quality standards are met without compromise.
• Knowledge of Quality Risk Management, CAPA, and regulatory reporting requirements.