Dishman Carbogen
Assistant Manager - API
- Location Bavla, Gujarat, IN
- Experience ~5-10 yrs
- Job type Full-time
- Posted 10 Oct 2026
You will be taken to Dishman Carbogen’s own careers page to apply. Job ID 1371182055.
Job description
- Ensure QC lab operations comply with cGMP, ICH, pharmacopoeial (USP/EP/IP) and regulatory requirements.
- Conduct periodic lab audits and walkthroughs covering sample management, reagent and standard control, glassware and column usage, and documentation practices.
- Oversee instrument qualification (DQ/IQ/OQ/PQ), calibration, preventive maintenance and periodic review.
- Verify reference standard and working standard qualification, storage and usage.
- Ensure stability study execution is compliant (chamber mapping, pull schedules, protocol adherence, trend review).
- Prepare the lab for regulatory and customer audits and support responses to observations.
- Review and approve Phase I (laboratory) and Phase II (full-scale) OOS investigations per the current regulatory guidance and the site SOP.
- Verify that retests, resamples and averaging are scientifically justified and not "testing into compliance".
- Evaluate OOT results from stability, process and in-process data using statistical trending, and initiate investigations when needed.
- Ensure root cause analysis is robust (5-Why, Fishbone, FMEA) and that CAPA is effective.
- Assess batch impact, including other batches, products and methods affected.
- Track OOS/OOT trends and present monthly metrics to management.
- Review and approve analytical method validation protocols and reports per ICH Q2(R2) and Q14 (specificity, linearity, accuracy, precision, LOD/LOQ, range, robustness).