Lead Investigator (Permanent / Secondment Opportunity)

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

Working as part of the Pharma Services business unit based in our global headquarters in Craigavon, the primary role of the Lead Investigator is to oversee and manage the timely investigation of deviations and CAPA’s. The successful candidate must ensure that investigations are performed and documented, with appropriate root cause determination and to ensure that CAPA actions are identified and implemented in line with procedural and regulatory expectations.

Lead Investigators will be aligned with operational areas and must work closely with the senior manager of that area to communicate, educate and ensure continuous improvement within those areas. The successful candidate will be part of a Lead Investigator team working closely with Quality Assurance to manage and support investigations in all business areas.

For a full list of job specific responsibilities please see attached Job Description.

Degree level qualification (or equivalent) *Note: significant relevant work experience and knowledge will be considered in lieu of degree*

GCSE (or equivalent) passes (Grade C or above) in Mathematics and English Language

Industry experience within a Pharmaceutical GMP environment

(The following criteria may be applied if a large pool of applicants exist)

Root Cause Analysis Training (Lean Six Sigma Qualification, 8D Problem Solving etc.)

Previous experience within a role involving investigation, data analysis and narrative report compilation is preferred

Previous technical writing experience preferred

Previous experience in supporting audits (customer and/or regulatory)