Site Head

17 hours ago

Boisar, Maharashtra, India NMS Consultant Full time ₹ 9,00,000 - ₹ 15,00,000 per year
  • To ensure operation at Plant is kept at the optimum level by constantly improving production efficiency , controlling cost and improving compliance.
  • Ensure compliance to CGMP/international regulatory norms.
  • Ensuring availability of all necessary Utilities, QC, SHE, Equipment and instruments for plant activities.
  • To facilitate in achieving targeted quantity as per the production plan by ensuring the quality, safety and environment standards .
  • Developing a competent team and managing talent by guiding, training and helping the team.
  • Creation of required manufacturing capacities (Plants and people) and competencies in terms of technology, people, training and systems.
  • Assessment, recommendation and approval of additional Manpower of all section at plant.
  • Recommend capex sanction of projects, new equipments for purpose of capacity enhancements .
  • Facilitate audits and ensure compliance to all the regulatory and statutory standards .
  • Facilitate introduction of New products, ANDA , Site transfer.
  • To ensure resolution of technical issues by coordinating with cross functional teams and leading improvements and changes as required.
  • Review Quality issue related to product, facilities and system and lead in the resolution of the issues.
  • Review of Market complaint and ensure that there is a reduction in market complaints (year on year basis)
  • Review and act on Out of specification (OOS), Out of trend (OOT) , CCP , QRM , failures and rejections.
  • Ensure periodic self inspection are carried out and actions arising are completed .
  • Keep update of Product, Processes, Equipment, Layout, CGMP Guidelines, stipulated by various regulatory Authorities and local authorities, destruction approvals.
  • Co ordinate with Government agencies, FDA / International Regulatory authorities,
  • Co ordinate with Corporate Commercial, Projects, Finance, HR, R&D, RA and production planning.

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