oracle
Executive, Quality Control
Amneal India
Visakhapatnam, IND
Full-time
Senior · 7+ years experience
Onsite
Discovered 3 weeks ago
LIMS
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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.
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.
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