Deputy Manager - Quality Control (API Plant)

Deputy Manager Quality Control (API Plant)

Location: Dahej, Gujarat
Department: Quality Control (QC)
Designation: Deputy Manager – QC
Experience: 8–12 Years
CTC: Up to 9.86 LPA
Industry: Pharmaceutical / API / Bulk Drug

Job Summary

We are looking for an experienced Deputy Manager – Quality Control to support and manage QC laboratory operations at our API manufacturing plant in Dahej.

The candidate will be responsible for analytical testing, review of results, laboratory compliance, OOS/OOT investigations, stability studies, method validation and ensuring adherence to cGMP, GLP and data integrity requirements.

Key Responsibilities

• Manage day-to-day QC laboratory operations for the API manufacturing facility.
• Ensure timely testing of raw materials, intermediates, in-process samples and finished APIs.
• Perform and review analytical testing using instruments such as HPLC, GC, UV, FTIR, KF, pH meter and other laboratory instruments.
• Review analytical results, test reports, specifications and Certificates of Analysis (CoA).
• Ensure compliance with cGMP, GLP, SOPs and data integrity requirements.
• Handle OOS, OOT, deviations, investigations and CAPA related to QC activities.
• Support analytical method validation, method verification and method transfer activities.
• Coordinate and monitor stability studies as per approved protocols.
• Ensure proper calibration, qualification and maintenance of QC laboratory instruments.
• Maintain proper QC documentation and ensure ALCOA+ / data integrity compliance.
• Support regulatory, customer and internal audits and ensure timely closure of observations.
• Coordinate with QA, Production, R&D and Engineering for quality-related activities.
• Monitor laboratory testing timelines and ensure timely release of materials/products.
• Train and develop QC personnel and ensure adherence to laboratory SOPs.
• Ensure compliance with laboratory safety and EHS requirements.
• Identify opportunities for improving laboratory efficiency and testing turnaround time.

Required Skills

• API / Bulk Drug Quality Control
• QC Laboratory Operations
• cGMP & GLP
• HPLC / GC / UV / FTIR / KF
• Analytical Method Validation
• Method Transfer / Verification
• Stability Studies
• OOS / OOT Investigation
• Deviation & CAPA
• Data Integrity / ALCOA+
• QC Documentation
• Regulatory / Customer Audit Support
• Laboratory Instrument Qualification & Calibration
• Team Handling

Education

M.Sc. Chemistry / M.Pharm / B.Pharm / equivalent qualification from a recognized institution.

Candidate Profile

• 8–12 years of relevant experience in Quality Control within Pharmaceutical / API / Bulk Drug manufacturing.
• Strong experience in API QC laboratory operations.
• Hands-on knowledge of analytical instruments, particularly HPLC and GC.
• Experience in OOS/OOT investigations, deviations, CAPA and stability studies.
• Good understanding of cGMP, GLP and data integrity requirements.
• Experience in QC documentation and analytical result review.
• Exposure to regulatory/customer audits will be preferred.
• Candidates from API / Bulk Drug manufacturing companies will be preferred.
• Good team-handling and communication skills.
• Candidate should be willing to work at Dahej, Gujarat.

Preferred Keywords

API | Bulk Drug | Pharmaceutical | API Manufacturing | Quality Control | QC | Analytical QC | QC Laboratory | cGMP | GLP | HPLC | GC | UV | FTIR | Karl Fischer | OOS | OOT | CAPA | Stability | Method Validation | Method Transfer | Data Integrity | ALCOA+ | Regulatory Audit

Apply / Share CV

Interested candidates can share their updated CV at:

[email protected]

Subject Line: Application – Deputy Manager QC – Dahej