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82 Glenmark Pharmaceuticals Jobs

General Manager- Contract Manufacturing

13-20 years

Mumbai

1 vacancy

General Manager- Contract Manufacturing

Glenmark Pharmaceuticals

posted 1hr ago

Job Role Insights

Flexible timing

Key skills for the job

Job Description

Role & responsibilities:

  • Develop and manage audit programs for new and existing Contract Manufacturers (CMOs), support technology transfers to CMOs and maintain and manage CMO related documentation.
  • Ensure that expenditure on audits is within budget. This shall be achieved by advance planning, clubbing audits in same geography, remote audits - after assessing risk.
  • Develop quality strategy for LL, TP sites based on the compliance risk and business risk.
  • Maintain an active surveillance of products within scope and ensure reputation of Glenmark is protected at all times.
  • Control testing costs by negotiation with PTL, clubbing tests together
  • Reduction in product quality issues through CIP & timely support from R&D
  • Introduce best industry practices at CMOs by periodic trainings & continuous monitoring
  • Regularly update vendor SOP for compliance & best industry practices
  • Successful regulatory inspections at CMOs & Nasik, without any critical observations
  • Reduction of invalid OOS & lab incidences
  • Ensure adherence to agreed SLA for testing & release of batches. Also make sure new product launches are within accepted timelines
  • Evaluate repeat complaints and or quality issues & initiate suitable CAPA
  • Ensure AVD proposals are handled & closed in time
  • Effective utilization of SAP / Track Wise / GYAN for process simplification & effective utilization of resources in VM team
  • Enhance in-house testing capabilities to reduce dependence on external labs
  • Prepare and execute robust vendor / supplier management program. Develop and manage a global audit program of existing API excipient, key raw materials and packaging materials vendors based on the risk evaluation and scoring input from the sites
  • Perform audits of new vendors as per request from R&D Quality, site Quality or other functions to ensure vendors quality systems are effective and meet standards.

Knowledge and Skills (Functional / Technical)

  • Experience in handling Quality Assurance elements in the area of contract manufacturing.
  • Regulatory Authorities Exposure, USFDA Audits
  • Awareness of Manufacturing Processes, Business Processes & Quality

Leadership/ Managerial Attributes

  • Excellent Leadership and team management skills
  • Very high level of ethical conduct and integrity
  • Strong decision making abilities
  • Excellent communication, interpersonal and influencing skills
  • Strong attention to detail and Quality focus



Employment Type: Full Time, Permanent

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