Senior Officer, Quality Control

Amneal Pharmaceuticals; Visakhapatnam District; Vor Ort; INR 1.800.000 - 3.000.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals LLC is seeking an Executive – Quality Control in Visakhapatnam, India. The role ensures smooth laboratory operations in a cGMP/GLP framework, reviews raw data, releases COAs, and maintains laboratory documentation.

You will coordinate investigations (OOS/OOT, deviations, CAPA) and train analysts while upholding SOPs and quality systems. The role requires strong analytical knowledge, instrument handling experience, and expertise in QC systems and LIMS, with responsibilities

Qualifikationen

• Proven ability to run QC operations in a cGMP/GLP environment.
• Experience handling analytical instruments and performing instrument maintenance.
• Strong knowledge of LIMS management and data integrity practices.
• Expertise in handling deviations, CAPA, OOS, OOT, incidents and investigations.
• Excellent documentation and data review skills; regulatory awareness.
• Effective communication, training, and team coordination abilities.

Aufgaben

• Follow cGMP, GLP, safety norms and company policies.
• Ensure SOPs, STPs, GTPs and lab procedures are implemented and followed.
• Review raw data and release Certificates of Analysis (COA).
• Maintain QC lab documentation and online data records.
• Monitor calibration schedules for all lab instruments.
• Handle incidents, deviations, OOS, OOT and CAPA closures.
• Lead investigations related to analytical deviations and incidents.
• Prepare and update SOPs, protocols, test plans and stability docs.
• Manage LIMS activities including master data creation and troubleshooting.
• Register and manage reference standards, working standards, instruments and columns in LIMS.
• Train analysts on LIMS processes and lab practices.
• Support qualification activities for LIMS modules and instruments.
• Ensure monthly electronic data verification and backup verification.
• Monitor analyst performance and lab performance metrics.

Kenntnisse

QC operations

Analytical instruments handling

LIMS management

Deviations, OOS, CAPA investigations

Documentation & recordkeeping

Regulatory knowledge (USFDA, WHO, MHRA

Communication and training

Ausbildung

Master's degree M. Sc. - Chemistry

Tools

LIMS

Laboratory instruments maintenance

Jobbeschreibung

Job Description

The Executive – Quality Control is responsible for ensuring smooth laboratory operations in compliance with cGMP, GLP, and regulatory requirements. The role includes handling analytical activities, reviewing raw data, maintaining laboratory documentation, instrument calibration and maintenance, LIMS management, and release of COA. The candidate should coordinate investigations related to OOS, OOT, deviations, incidents, and CAPA, while ensuring timely closure and compliance. The position also requires training analysts, maintaining quality systems, supporting audits, and ensuring proper implementation of SOPs and laboratory procedures.

This role demands strong analytical knowledge, documentation skills, instrument handling experience, and expertise in Quality Control systems and LIMS.

Key Responsibilities

• Follow and maintain cGMP, GLP, safety norms, and company policies.
• Ensure implementation and compliance of SOPs, STPs, GTPs, and laboratory procedures.
• Review completed raw data and release Certificate of Analysis (COA).
• Maintain all QC laboratory documentation, records, and online raw data monitoring.
• Review and monitor calibration schedules for all laboratory instruments.
• Handle laboratory incidents, deviations, OOS, OOT, and CAPA closure within timelines.
• Coordinate investigations related to analytical incidents and deviations.
• Preparation, review, and updation of SOPs, protocols, test plans, and stability documents.
• Manage LIMS activities including master creation, review, troubleshooting, and user training.
• Registration and management of reference standards, working standards, instruments, and columns in LIMS.
• Conduct analyst training on current updates, LIMS processes, and laboratory practices.
• Support qualification activities for LIMS modules and analytical instruments.
• Ensure monthly electronic data verification and backup data verification.
• Monitor analyst evaluations and laboratory performance.

Required Skills:

• Strong knowledge of Quality Control laboratory operations.
• Experience in handling analytical instruments and maintenance activities.
• Good knowledge of LIMS management and troubleshooting.
• Expertise in handling deviations, CAPA, OOS, OOT, incidents, and investigations.
• Strong documentation and review skills.
• Good communication, training, and team coordination skills.
• Knowledge of regulatory requirements including USFDA, WHO, MHRA, and GMP guidelines.

Qualifications

• Master's degree M. Sc. - Chemistry

Experience

• 7 years