Job Description
Job Title:
Assistant Manager - API
Department:
Quality
Location (Branch):
Bavla
Posting Start Date:
10/10/2026
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).
- Review method verification for compendial methods and method transfer protocols and reports.
- Ensure the analytical method lifecycle is controlled, including revalidation after changes.
- Verify system suitability criteria and the scientific justification for specifications.
- Review cleaning verification and residual solvent/impurity methods, including genotoxic impurity methods where applicable.
- Perform second-level review of raw data, chromatograms, spectra, audit trails, calculations and worksheets for release, stability and in-process samples.
- Verify the integrity of manual and electronic data (HPLC/GC/ICP/KF/UV/IR, CDS such as Empower or Chromeleon).
- Review audit trails for deletions, reprocessing, manual integration, sequence changes and unauthorized access.
- Ensure Certificates of Analysis are accurate before QA release.
- Ensure compliance with ALCOA+ and data integrity principles (21 CFR Part 11, MHRA and WHO guidance).
- Review and close lab incidents such as sample mix-ups, instrument failures, spillage, calculation errors, documentation errors and missed calibrations.
- Decide whether an incident needs escalation to a deviation or OOS investigation.
- Ensure timely investigation, impact assessment and documented closure.
- Evaluate and classify lab-related deviations (minor / major / critical).
- Review root cause analysis, product impact assessment, and corrective and preventive actions.
- Monitor CAPA effectiveness and on-time closure.
- Present deviation and CAPA trends in quality review meetings.
- Review lab-related change controls (methods, specifications, instruments, vendors).
- Review and approve SOPs, specifications, STPs and templates for the lab.
- Support Annual Product Quality Review (APQR) and Management Review inputs.
- Participate in supplier and contract-lab qualification and audits.
- Train QC and QA staff on GDP, data integrity, OOS/OOT and investigation writing.
- Guide and mentor Officers and Executives in the analytical QA team.
- Coordinate with QC, Production, Regulatory Affairs, R&D/ADL and Validation.