Job Description

  • To implement and follow the GMP, GLP, Safety norms and adhere to company's policies.
  • Review of all the procedures, protocols and QC related change controls prior to the approval as applicable.
  • Review and Harmonization of Standard Operating Procedures for group laboratories.
  • Coordinate with site QA and QC laboratories for the implementation of Corporate Procedures, applications and initiatives.
  • Review the QMS elements like Incidents, OOT, Change Controls & OOS investigations etc. (As applicable) and provide technical guidance for resolution.
  • Review the electronic data generated during analysis and QC instruments/LIMS audit trails for compliance.
  • Coordinating with all the units while investigating the Market Complaints and CAPA implementation.
  • Carry out the internal audits in Hetero Laboratories and follow-up for closeout of observations if any.
  • Comprehensive assessment on Laboratory QMS events for identifying suitable CAPAs.
  • Preparation and demonstration of Training modules, imparting training sessions on Human Errors and recurring laboratory incidents.
  • Performing Gap analysis with respect to the compliance of laboratory equipment/instruments and laboratory control systems.
  • Coordination with plant and AR&D for Method transfers, validations and method optimizations.
  • Any other jobs as assigned by Reporting Head.
  • Reports to Associate Vice President – Corporate Quality Control.


Job Details

Role Level: Mid-Level Work Type: Full-Time
Country: India City: Andhra University ,Andhra Pradesh
Company Website: http://www.hetero.com Job Function: General Management
Company Industry/
Sector:
Pharmaceutical Manufacturing

What We Offer


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