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.