Apeiron Consultancy Ltd

Job Description: Senior QA Officer – Investigation & Change Control

Department: Quality Assurance

Reports To: QA Manager

Role Summary:

The Senior QA Officer (Investigations) is the lead investigator for deviations, out-of-specification (OOS) results, and product complaints. This role drives the root cause analysis process and manages the Change Control system to ensure that all product/process changes are thoroughly evaluated for their impact on product quality and patient safety.

Key Responsibilities:

Deviation Management: Lead investigations into deviations, OOS, and adverse events. Facilitate cross-functional investigation teams to identify true root causes.

Root Cause Analysis: Utilize formal investigation tools (e.g., 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis) to prevent recurrence.

CAPA: Develop, implement, and follow up on Corrective and Preventive Actions (CAPAs) to ensure timely closure.

Change Control: Review and evaluate Change Control requests to assess the potential impact on validated systems and product quality.

Risk Assessment: Conduct Quality Risk Management (QRM) exercises (FMEA) to assess the risk level of deviations and change requests.

Product Review: Contribute to the Annual Product Quality Review (APQR) by analyzing investigation trends and stability data.

Regulatory Reporting: Evaluate deviations for reportability to regulatory authorities (e.g., MHRA, FDA) and support the reporting process.

Qualifications & Experience:

Education: Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or Engineering.

Experience: 5–7 years of experience in a Quality Assurance/Compliance role within pharmaceuticals/biotech, with at least 3 years specifically handling investigations/change control.

Technical Skills: Certified Quality Auditor (CQA) or Six Sigma Green Belt is an advantage.

Key Competencies:

• 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.

• Lead investigations into deviations, OOS, and adverse events.
• 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.

• Logical reasoning
• Problem-solving
• Conflict management
• Negotiation
• Assertiveness
• Certified Quality Auditor (CQA) (advantage)
• Six Sigma Green Belt (advantage)

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or Engineering.
• 5–7 years of experience in a Quality Assurance/Compliance role within pharmaceuticals/biotech.
• At least 3 years specifically handling investigations/change control.