Job Purpose To lead the Quality Control function at an API manufacturing facility, ensuring timely testing and release of raw materials, intermediates, in-process samples, finished APIs and stability samples in compliance with cGMP, applicable pharmacopoeial standards and regulatory requirements.

The role is responsible for laboratory operations, analytical method management, data integrity, investigations, instrument qualification, team development and continuous improvement of QC systems.

- Key Responsibilities

A. QC Laboratory Operations
- Lead day-to-day operations of the Quality Control laboratory for API and intermediate manufacturing.
- Ensure timely analysis of raw materials, intermediates, in-process samples, finished products and stability samples.
- Review and approve analytical results, laboratory records and certificates of analysis (CoAs), as authorized.
- Ensure testing is performed according to approved specifications, analytical methods, SOPs and applicable pharmacopoeial requirements.
- Coordinate with Production, QA, R&D;, Warehouse and Regulatory Affairs to support manufacturing and product release timelines.
- Monitor sample receipt, testing turnaround time, pending analysis and laboratory workload.
- Ensure proper handling, storage, retention and disposal of laboratory samples.

B. Analytical Testing & Instrumentation
- Ensure effective utilization and maintenance of analytical instruments, including:
- HPLC and GC
- UV-Visible spectrophotometer
- FTIR
- Karl Fischer titrator
- pH meter and conductivity meter
- Dissolution or other applicable analytical systems, where relevant
- Wet chemistry and titration equipment
- Oversee testing for assay, related substances, impurities, residual solvents, water content and other relevant API quality attributes.
- Ensure instrument calibration, qualification, preventive maintenance and timely servicing.
- Review chromatograms, calculations, analytical worksheets and instrument-generated data.
- Ensure proper handling and documentation of reference standards, working standards, reagents and volumetric solutions.

C. cGMP & Regulatory Compliance
- Ensure compliance with applicable cGMP requirements, approved specifications, pharmacopoeial standards and site quality procedures.
- Maintain inspection readiness for regulatory inspections and customer audits.
- Ensure laboratory documentation is complete, accurate, traceable and contemporaneous.
- Review and maintain QC SOPs, analytical methods, specifications,



test procedures and laboratory records.
- Ensure compliance with data integrity principles, including ALCOA+.
- Coordinate with QA for deviations, change controls, CAPA and laboratory-related quality events.
- Support audits and inspections by providing QC records, analytical data and technical explanations.

D. OOS, OOT & Laboratory Investigations
- Lead or coordinate investigations related to:
- Out-of-Specification (OOS) results
- Out-of-Trend (OOT) results
- Atypical results
- Invalid analytical runs
- Laboratory errors and deviations
- Ensure scientifically justified investigations with appropriate documentation and approvals.
- Identify root causes and implement effective corrective and preventive actions.
- Review recurring laboratory issues and drive continuous improvement.
- Ensure investigations follow approved procedures and applicable regulatory expectations.

E. Analytical Method Validation & Transfer
- Coordinate analytical method validation, verification and transfer in collaboration with R&D;, QA and other relevant functions.
- Ensure methods are suitable for their intended purpose and comply with applicable requirements.
- Support method development and troubleshooting for complex API matrices and impurity profiles.
- Review validation protocols, reports and analytical documentation as per assigned authorization.
- Support implementation of revised specifications and analytical methods following approved change control.

F. Stability Studies & Reference Standards
- Coordinate stability testing of APIs and intermediates as per approved protocols and applicable requirements.
- Ensure samples are tested within approved timelines and stability data is reviewed appropriately.
- Monitor stability chambers and ensure temperature/humidity monitoring, calibration and alarm management, where applicable.
- Ensure appropriate qualification and management of reference standards and working standards.
- Support stability trend evaluation and investigation of atypical results.

G. Laboratory Compliance & Data Integrity




- Ensure compliance with data integrity requirements across manual and computerized laboratory systems.
- Ensure proper access control, audit-trail review, electronic data retention and backup arrangements, as applicable.
- Ensure raw data, chromatograms, calculations and analytical records are complete and retrievable.
- Prevent unauthorized data changes, undocumented testing and inappropriate reinjection or reprocessing.
- Ensure computerized laboratory systems remain in a validated state, in coordination with QA and IT.

H. Team Management & Development
- Lead and supervise QC analysts, chemists and laboratory support personnel.
- Allocate work based on sample priority, analyst competency and laboratory workload.
- Train team members on analytical techniques, GMP documentation, safety and data integrity.
- Assess analyst competency and ensure appropriate authorization for assigned testing.
- Monitor team productivity, testing accuracy, investigation quality and turnaround time.
- Promote a culture of scientific integrity, accountability and continuous improvement.

I. Laboratory Safety & Cost Management
- Ensure safe handling of solvents, chemicals, reagents and laboratory waste.
- Ensure availability of laboratory consumables, reference standards and critical reagents.
- Manage laboratory budgets and optimize consumable and instrument-service costs.
- Ensure compliance with PPE, chemical storage, fire safety and waste-disposal procedures.

3. Qualification
- M.Sc. in Analytical Chemistry, Organic Chemistry or Pharmaceutical Chemistry preferred.
- M.Pharm in Pharmaceutical Analysis or a relevant discipline may also be considered.
- B.Pharm may be considered where supported by substantial relevant API QC experience and the applicable role requirements.

4. Experience
- 10–15 years of relevant experience in Quality Control within API, bulk drugs, intermediates or pharmaceutical manufacturing.
- At least 3–5 years in a supervisory or laboratory leadership role, depending on the site's organizational structure.
- Strong hands-on experience in HPLC, GC, analytical testing, laboratory documentation and investigation management.
- Experience in regulatory inspections, data integrity, analytical method validation and OOS/OOT investigations is preferred.
- Should have through knowledge on GAMP5 / CSV
- Should have good knowledge on 21 CFR part 11 compliance and data integrity guideline.
- Positive knowledge on OOS guideline, root cause analysis and CAPA.

📌 AGM:- QC (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar