Assistant Manager, Quality Control

Endo Pharmaceuticals; Chennai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Endo Pharmaceuticals in India seeks a Quality Control Assistant Manager in Chennai to coordinate day-to-day laboratory operations, ensuring GMP compliance and timely analytical testing.

You will lead QC analysts, review data, and drive CAPA implementation, documentation control, and SOP lifecycle management to maintain inspection readiness.

The role emphasizes cross-functional collaboration with QA, Manufacturing, Regulatory Affairs, and R&D to sustain product quality and regulatory compliance.

Qualifications

• Experience with cGMP, data integrity, and regulatory expectations.
• Proficient in SOP development, review, and document control.
• Proven ability to lead investigations (OOS/OOT), CAPAs, and root-cause analyses.

Responsibilities

• Supervising QC analysts and coordinating laboratory resources.
• Reviewing and approving QC documents, data, and certificates.
• Ensuring compliance with cGMP, SOPs, safety guidelines, and regulatory expectations.

Skills

GMP compliance

Data integrity

Documentation control

Root cause analysis

CAPA implementation

SOP lifecycle

Training & coaching

Laboratory management

Cross-functional collaboration

Tools

HPLC

GC

LC-MS

Job description

Job Description Summary

As a Quality Control Assistant Manager, responsible for coordinating and overseeing day-to-day laboratory operations to ensure compliance with current GMP, regulatory requirements, and internal quality standards. The role involves effective planning, supervision, and monitoring of group activities, ensuring timely completion of analytical testing, investigations, and laboratory commitments. Experienced Quality Control professional with expertise in laboratory management, analytical review, GMP compliance, investigation management, documentation control, SOP and analytical method lifecycle management, personnel training, and regulatory compliance. Proven ability to lead laboratory teams, ensure data integrity, maintain inspection readiness, and deliver quality objectives through effective planning, supervision, and continuous process improvement.

Job Description

• Supervising and coordinating the activities of QC analysts and ensuring optimal utilization of laboratory resources.
• Reviewing and approving quality control documents, including analytical data, laboratory records, stability studies, investigations, protocols, reports, and certificates.
• Ensuring laboratory compliance with cGMP, data integrity requirements, SOPs, safety guidelines, and regulatory expectations during routine operations.
• Leading and participating in laboratory investigations related to OOS, OOT, deviations, atypical results, and laboratory incidents, including root cause analysis and implementation of CAPAs.
• Preparing, reviewing, revising, and maintaining Standard Operating Procedures (SOPs) and other controlled quality documents.
• Reviewing, preparing, and updating specifications (SPECs), Standard Test Procedures (STPs), analytical methods, protocols, and related quality system documents.
• Providing technical guidance and troubleshooting support for chromatographic and laboratory-related issues.
• Planning and conducting training programs to enhance personnel competency and ensure compliance with current procedures and regulatory requirements.
• Monitoring analyst qualifications, training effectiveness, and periodic evaluations.
• Coordinating instrument qualification, calibration, maintenance activities, and ensuring laboratory equipment remains in a compliant state.
• Supporting method validation, method transfer, verification, and stability studies as per regulatory requirements.
• Collaborating with cross-functional departments including QA, Manufacturing, Regulatory Affairs, and R&D to support product quality and compliance objectives.
• Driving continuous improvement initiatives aimed at improving laboratory efficiency, compliance, and operational excellence.

To take up any additional responsibilities assigned by the Manager or QC Head.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.