Role overview
Senior hands-on SME who assesses and remediates the quality management system, conducts and reviews investigations, and drives CAPA backlog reduction and effectiveness. Combines quality systems, investigation and CAPA expertise in a single profile.
Key responsibilities
- Assess and improve QMS processes: deviations, CAPA, change control, audits, management review
- Perform independent reviews of deviations and OOS; lead scientific root-cause and product-impact assessments
- Write and remediate investigation reports to inspection-ready standard; support disposition decisions (final approval remains with the client)
- Reduce investigation and CAPA backlogs through risk-based segmentation and closure acceleration
- Design and execute CAPA effectiveness checks; assess overdue items and prevent recurrence
- Revise SOPs, forms and templates; deliver role-based training to site owners
- Track throughput, cycle time and first-time quality metrics for weekly reporting
Mandatory requirements
- 5+ years assessing and improving pharmaceutical QMS (deviation, CAPA, audit, management review)
- 5+ years in deviation investigations, root-cause analysis (e.g. 5 Whys, Ishikawa, Kepner-Tregoe) and technical writing
- Demonstrated experience designing and executing CAPA effectiveness checks
- Experience with electronic QMS tools (e.g. TrackWise, Veeva Vault QMS, MasterControl)
Plus the common requirements listed on page 1.
Preferred qualifications
- Laboratory / QC background with OOS and OOT investigation experience
- Experience in backlog-reduction or remediation programs
- Solid oral dosage experience
- Root-cause or human-error reduction certification
