Assistant General Manager, Quality Assurance

Essential Functions

• Responsible for cGMP compliance review in QC laboratory
• Responsible tenure the completeness of the analytical documents and approval of CoA of Raw materials, packaging materials, In-process, finished products, stability study intended for submission, validation & commercial batches.
• Responsible to perform / review of the investigation for Quality issues like OOS, Deviations, Incidents, CSIR of QC laboratory
• Responsible to ensure the implementation of CAPAs recommended in OOS, OOAL, Incidents and deviations related laboratory.
• Responsible for the review of Change controls related to QC laboratory.
• Responsible for the review of chromatographic and non-chromatographic data in Empower / LIMS and its audit trail tenure the data integrity.
• Responsible for the review and approve of LIMS audit trail for Plant Locations tenure the data integrity.
• Participates in the development and implementation of SOPs for laboratory compliance or relevant QC functions.
• To ensure the adequacy of Standardization/Characterization data of working/Impurity standards in QC.
• To review and approve Quality control documents like qualification documents /Calibration report of instruments.
• Responsible to impart trainings the subordinates and other personnel for development.
• Responsible for review and approve of Raw material sample quantity evaluation form cum list and raw material storage condition for the materials applicable for Plant Locations.
• Responsible for review and approve of reduce and enhance reduce testing report of raw materials and packaging materials.
• Responsible for review of Elemental impurity and Nitrosamine impurity risk assessment report of the products applicable for plant locations.
• Responsible for management of manufacturer address of materials in BLPS software and approval of GRN in BLPS software.
• Responsible to review and approval of stability protocol in LIMS, Miscellaneous study protocols & related reports in laboratory.
  

Additional Responsibilities:

• To perform other activities assigned by HOD
  

Education

QUALIFICATIONS

• Bachelors Degree (BA/BS) B. Pharma - Required
• Master Degree (MS/MA) M. Sc - Required
• Master Degree (MS/MA) M. Pharma - Preferred
  

Experience

• 12 years or more in 12 - 15 Years
  

Skills

• Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced
• Validation Master Plan (VMP) Development & Execution - Advanced
• Process Validation (PV) for Oncological Injectables - Advanced
• Cleaning Validation (CIP/SIP) & Residue Limit Justification - Advanced
• Aseptic Process Validation (Media Fill Studies) - Advanced
• Sterilization Validation - Advanced
• Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery
• Environmental Monitoring & HVAC Qualification - Advanced
• Deviation Handling, CAPA & Change Control in Validation - Mastery
• Analytical Quality Assurance - Advanced
• Equipment & Facility knowledge - Advanced
• Investigation - Mastery
  

Specialized Knowledge: Licenses:

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