Sr Officer, Quality Control
Amneal Pharmaceuticals · Visakhapatnam · onsite · Posted 42d ago
Undisclosed7–12 yrsfulltimeSourced from
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About this role
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 maintece, 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.
- Undertake any other responsibilities assigned by QC Head / Department Head.
- Strong knowledge of Quality Control laboratory operations.
- Experience in handling analytical instruments and maintece 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.
Education:
- Masters degree M. Sc. - Chemistry
Experience:
- 7 years
Specialized Knowledge: Licenses:
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.
Sourced from naukri
Skills
CGMPTroubleshootinglaboratory instrumentsauditsChemistryData VerificationCAPAInstrument Handlinginstrument calibrationQuality Systemslaboratory operationsQuality ControloperationsmaintenancecomplianceQC
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
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