QC API - Investigations team

Required Skills and Qualifications for Investigations team

1.Communication & Documentation :

Excellent written and verbal communication skills.

Proficient in drafting technical reports, investigation summaries, and audit responses.

2.Technical Expertise in Laboratory Instruments :

Hands-on knowledge of analytical instruments such as HPLC, GC, UV, IR, KF, etc.

Sound understanding of instrument qualification, calibration, and troubleshooting.

3.Risk Assessment :

Experience in performing and documenting quality risk assessments.

4.Investigation Experience :

Deep knowledge of regulatory expectations related to OOS, OOT, deviations, and laboratory incidents.

Proven experience in investigation lifecycle management and CAPA effectiveness.

5.Audit Handling :

Experience in handling audits (customer, regulatory) and preparing effective, timely responses to observations.

Must have worked in an API manufacturing environment with sound understanding of GMP and data integrity principles.

Skills Required

Risk Assessment, Documentation, Investigation, Communication