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Senior Officer, Quality Control

Amneal India
Visakhapatnam, IND
Full-time
Senior · 7+ years experience
Onsite
Discovered 1 weeks ago

Full Job Posting

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.

Qualifications

  • Education:
  • Master's degree M. Sc. - Chemistry
  • 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.
  • 7 years
  • Specialized Knowledge: Licenses

Experience:

  • Specialized Knowledge: Licenses:

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