HE

DGM/GM - Quality Control (API ONCO)

Hetero Labs Limited
Hyderabad3-11 LPA Posted 14 May 2025
FULL TIME
Risk Assessment
Change Control
Quality Control

Job Description


  • Responsible for preparing annual production plan in co-ordination with SCM and production planning
  • team based on customer requirement & ensuring the execution effectively to meet the timelines
  • Make available resources like manpower, utilities and equipment etc. and indenting of Raw materials
  • and Packing materials as per production planning.
  • Assisting timely installation, commissioning and validation of the process equipments in the unit.
  • Ensures the manufactured products and facility meet the quality, safety and environmental requirements
  • and regulations governing an API manufacturing operation.
  • Review of trends for different stages of product yield and quality.
  • Execution of new projects including technology transfer and scale up under the guidance of
  • department head.
  • Ensure deviations, OOT & OOS are investigated and necessary correction, corrective and preventive
  • actions are implemented.
  • Review of both cleaning and process validation reports.
  • Preparation of on jobs training schedule and its implementation
  • Providing training to team with respect to preparation in view of audits (internal, external and
  • regulatory)
  • Coordinating with other departments for varies services as Maintenance, Quality Control, Quality
  • Assurance, ETP, SHE, R& D and Warehouse.
  • Preparation of campaign report, process flow diagram, equipment occupancy chart, daily report,
  • monthly report etc.
  • Making the Block ready for both external and internal audits.
  • Minimizing bottlenecks for achieving high productivity by maximization of material & machine
  • Raising and closing of Change Controls as per the laid down procedure.
  • Co-ordination for the reparation of risk assessment, Change controls, deviation, SOPs based on the
  • requirement

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