Pharma Quality Investigator: CAPA & Deviation Lead

Hira Ni; United Kingdom; Remote; GBP 42,000 - 65,000; Full time

Job summary

HIRANI is seeking a Lead Investigator to oversee and manage timely investigations of deviations and CAPAs within its Pharma Services unit at the Craigavon headquarters. The role requires ensuring investigations are well-documented with robust root-cause analysis and CAPA actions aligned to regulatory expectations.

The Lead Investigator will work closely with operational leads and the Quality Assurance team to educate, communicate and drive continuous improvement across areas.

Qualifications

• Degree level qualification (or equivalent) is required or significant relevant work experience in lieu of degree.
• GCSE passes (Maths and English, Grade C or above).
• Experience in a Pharmaceutical GMP environment.
• Root Cause Analysis training (Lean Six Sigma, 8D etc.).
• Previous experience in investigations, data analysis and narrative report compilation preferred.
• Previous experience in supporting audits (customer and/or regulatory).

Responsibilities

• Oversee and manage timely investigations of deviations and CAPAs.
• Ensure investigations are performed and documented with appropriate root cause determination.
• Identify and implement CAPA actions in line with procedural and regulatory expectations.
• Align with operational areas and collaborate with QA to support investigations across business areas.

Skills

Investigation

Data analysis

Technical reporting

Audit support

Education

Degree level qualification or equivalent

GCSE (Maths & English)

Tools

Lean Six Sigma

8D Problem Solving

Job description

HIRANI is seeking a Lead Investigator to oversee and manage timely investigations of deviations and CAPAs within its Pharma Services unit at the Craigavon headquarters. The role requires ensuring investigations are well-documented with robust root-cause analysis and CAPA actions aligned to regulatory expectations.

The Lead Investigator will work closely with operational leads and the Quality Assurance team to educate, communicate and drive continuous improvement across areas.