Assistant Manager, Quality Control

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

Job summary

Endo is seeking a Quality Control Assistant Manager to coordinate day-to-day laboratory operations and ensure adherence to cGMP and regulatory standards. You will supervise QC analysts, review QC documents, and drive investigations with root cause analysis and CAPA.

The role requires leadership in laboratory management, data integrity, SOP lifecycle handling, and staff training to maintain inspection readiness and continuous improvement of processes.

Qualifications

• Experience with GMP compliance and quality control in a laboratory setting.
• Ability to lead investigations (OOS/OOT) and implement CAPAs.
• Experience in SOP lifecycle management and analytical method validation/transfer.

Responsibilities

• Supervise QC analysts and optimize laboratory resource utilization.
• Review and approve QC documents, lab records, specs, procedures, and reports.
• Ensure cGMP compliance, data integrity, and regulatory expectations during routine operations.
• Lead investigations for deviations and incidents with root-cause analysis and CAPA implementation.
• Prepare, review, and maintain SOPs and quality documents (SPECs, STPs, methods).
• Provide troubleshooting support for chromatographic and lab issues and guide training programs.

Skills

Quality control

GMP compliance

Laboratory management

Data integrity

CAPA implementation

Tools

LIMS

Chromatography

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.