Assistant Manager Quality Control

Par Health, Inc.; Kanchipuram; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Par Health, Inc. is seeking a Quality Control Assistant Manager to coordinate day-to-day laboratory operations, ensuring GMP compliance and adherence to internal quality standards. The role emphasizes planning, supervision, and continuous process improvements across QC activities.

The candidate will lead QC analysts, review analytical data and records, manage investigations (OOS/OOT), and drive methods validation, calibration, and documentation controls in a regulated lab environment.

Qualifications

• Experience with GMP and data integrity in a QC lab.
• Knowledge of investigations and root cause analyses (OOS/OOT).
• Familiarity with SOP lifecycle management and quality document control.
• Ability to lead laboratory teams and ensure inspection readiness.

Responsibilities

• Supervise QC analysts and optimize use of lab resources.
• Review and approve QC documents, data, certificates, and stability studies.
• Ensure cGMP compliance and data integrity in routine operations.
• Lead laboratory investigations including CAPA planning and execution.
• Maintain SOPs, STPs, analytical methods, and related quality documents.
• Provide training to personnel and monitor qualification and performance.

Skills

GMP Knowledge

Quality Assurance

Documentation Control

CAPA

Regulatory Compliance

Team Leadership

Data Integrity

Education

Bachelor’s degree in Chemistry/QA

Tools

Chromatography

Instrument Calibration

Job description

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.

• 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.