Senior Manager - Quality Control (API Plant)

Cadila Pharmaceuticals Limited; Dahej; On-site; INR 1,078,000 - 1,796,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Dahej, Gujarat seeks a Senior Manager – Quality Control to lead the QC function at the API manufacturing plant.

The role covers laboratory operations, analytical testing, product release, investigations, method validation and regulatory audit readiness. You will coordinate with QA, Production, R&D, Regulatory Affairs and Engineering to drive improvements and ensure data integrity.

Qualifications

• 14–20 years of experience in Quality Control within Pharmaceutical / API / Bulk Drug manufacturing.
• Strong hands‑on experience in API QC laboratory operations.
• Experience in managing and leading QC teams.
• Strong knowledge of cGMP, GLP, data integrity and regulatory compliance.
• Experience in OOS/OOT investigations, CAPA, method validation and stability studies.
• Exposure to regulatory and customer audits will be preferred.

Responsibilities

• Lead and manage overall QC operations for the API manufacturing facility.
• Ensure timely testing and release of raw materials, intermediates, in-process samples and finished APIs.
• Manage analytical testing using HPLC, GC, UV, FTIR, KF, pH meter, Polarimeter, TOC and other laboratory instruments.
• Review and approve analytical results, test reports, specifications and CoA.
• Ensure compliance with cGMP, GLP, SOPs, data integrity and regulatory requirements.
• Handle and review OOS, OOT, deviations, investigations, CAPA and change controls.
• Lead analytical method validation, method verification and method transfer activities.
• Manage stability studies as per approved protocols and regulatory requirements.
• Ensure proper calibration, qualification and preventive maintenance of QC laboratory instruments.
• Ensure compliance with ALCOA+ and data integrity requirements.
• Support and lead regulatory, customer and internal audits.
• Ensure timely closure of audit observations, CAPA and compliance actions.
• Coordinate with QA, Production, R&D, Regulatory Affairs and Engineering for quality-related activities.
• Monitor QC KPIs including testing turnaround time, investigation closure and laboratory performance.
• Lead, train and develop the QC team to ensure competency and productivity.
• Ensure laboratory safety and compliance with applicable EHS requirements.
• Support QC manpower planning, laboratory budgeting, equipment procurement and CapEx/OpEx activities.
• Drive continuous improvement initiatives within the QC laboratory.

Skills

API QC

QC Laboratory Mgmt

cGMP & GLP

HPLC / GC / UV / FTIR

Analytical Method Validation

Stability Studies

OOS / OOT Investigation

CAPA Management

Data Integrity / ALCOA+

Regulatory Audits

Team Leadership

Education

M.Sc. / M.Pharm / B.Pharm / M.Sc. Chemistry

Job description

Senior Manager - Quality Control (API Plant)

Location: Dahej, Gujarat
Department: Quality Control (QC)
Designation: Senior Manager QC
Experience: 14–20 Years
CTC: Up to 17.96 LPA
Industry: Pharmaceutical / API / Bulk Drug

Job Summary

We are looking for an experienced Senior Manager – Quality Control to lead the Quality Control function at our API manufacturing plant in Dahej.

The candidate will be responsible for overall QC laboratory operations, analytical testing, product release, compliance, investigations, stability studies, analytical method validation and regulatory/customer audit readiness.

Key Responsibilities

• Lead and manage overall QC operations for the API manufacturing facility.
• Ensure timely testing and release of raw materials, intermediates, in-process samples and finished APIs.
• Manage analytical testing using HPLC, GC, UV, FTIR, KF, pH meter, Polarimeter, TOC and other laboratory instruments.
• Review and approve analytical results, test reports, specifications and Certificates of Analysis (CoA).
• Ensure compliance with cGMP, GLP, SOPs, data integrity and regulatory requirements.
• Handle and review OOS, OOT, deviations, investigations, CAPA and change controls.
• Lead analytical method validation, method verification and method transfer activities.
• Manage stability studies as per approved protocols and regulatory requirements.
• Ensure proper calibration, qualification and preventive maintenance of QC laboratory instruments.
• Ensure compliance with ALCOA+ and data integrity requirements.
• Support and lead regulatory, customer and internal audits.
• Ensure timely closure of audit observations, CAPA and compliance actions.
• Coordinate with QA, Production, R&D, Regulatory Affairs and Engineering for quality-related activities.
• Monitor QC KPIs including testing turnaround time, investigation closure and laboratory performance.
• Lead, train and develop the QC team to ensure competency and productivity.
• Ensure laboratory safety and compliance with applicable EHS requirements.
• Support QC manpower planning, laboratory budgeting, equipment procurement and CapEx/OpEx activities.
• Drive continuous improvement initiatives within the QC laboratory.

Required Skills

• API / Bulk Drug Quality Control
• QC Laboratory Management
• cGMP & GLP
• HPLC / GC / UV / FTIR / KF
• Analytical Method Validation & Transfer
• Stability Studies
• OOS / OOT Investigation
• Deviation & CAPA Management
• Data Integrity / ALCOA+
• Regulatory & Customer Audits
• Laboratory Instrument Qualification & Calibration
• Root Cause Analysis
• Team Leadership & People Management

Education

M.Sc. / M.Pharm / B.Pharm / M.Sc. Chemistry or equivalent qualification.

Candidate Profile

• 14–20 years of relevant experience in Quality Control within Pharmaceutical / API / Bulk Drug manufacturing.
• Strong hands‑on experience in API QC laboratory operations.
• Experience in managing and leading QC teams.
• Strong knowledge of cGMP, GLP, data integrity and regulatory compliance.
• Experience in OOS/OOT investigations, CAPA, method validation and stability studies.
• Exposure to regulatory and customer audits will be preferred.
• Candidates from API / Bulk Drug manufacturing companies will be preferred.
• Candidate should be willing to work at Dahej, Gujarat.

Preferred Keywords

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