The main objective of the role is to manager the Lead Investigator team, ensuring 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.
The Team Leader will be working closely with the senior managers of other business areas to achieve PQS metric, communicate, educate and ensure continuous improvement within those areas.
As part of a busy team within a rapidly growing organisation, operating within a challenging industry you will benefit from the numerous personal and professional developmental opportunities available throughout the Almac group.
This role may require travel and additional coverage beyond normal working hours on a regular basis. It is a condition of your employment that you are able to fulfil this requirement of the role.
- Level 5 qualification OR significant relevant work experience and knowledge will be considered in lieu of degree
- GCSE English and Mathematics or equivalent (Grade C or above)
- Industry experience within a Pharmaceutical GMP environment
- Experience of line management
- Knowledge on Root Cause Analysis technique
- 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
- Previous technical writing experience
- Previous experience in supporting audits (customer or regulatory)