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)
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Lead Investigator (Permanent / Secondment Opportunity) employer: Hira Ni
The Health Innovation Research Alliance Northern Ireland (HIRANI) is an exceptional employer, offering a dynamic hybrid work environment in the heart of Belfast that fosters collaboration and innovation in the health and life sciences sector. With a strong commitment to employee growth, HIRANI provides opportunities for professional development through engaging projects and partnerships with universities, healthcare providers, and industry leaders. Our inclusive work culture prioritises communication and teamwork, ensuring that every team member can contribute meaningfully to our mission of promoting health and prosperity across Northern Ireland.
