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Job Description
- 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.
Skills
Plant ManagementPlant OperationsManpower ManagementSite SupervisionSite OperationsProduction OperationsSite ExecutionSafety ManagementIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
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