- Excellent experience in Formulation Production, CGMP guidelines

- Experience in handling entire production unit right from Planning to Execution

- Accountable for production, productivity, quality of our process & products

- Monitor, control and correct all critical parameters at all stages of production

- Ensure proper utilization of resources

- Be thoroughly conversant with all critical activities of Tablet and Capsule Production

- Ensure production and storage of all products according to the set guidelines

- Conformation to WHO- GMP guidelines and other good practices

- Ensure in-process QC and its strict implementation

- Ensure proper consumption of Raw and Packing Material and also final yield of the product

- Capable to face plant audits by such outside local/international authorities

- Manage process machineries/equipment's and also the utilities which are getting supplied in the production areas

- Provide insight and direction to the associates in the operating unit in accordance with the organization's policies and procedures

- Ensure that all the functional / operational and safety procedures are adhered during the routine working

- Planning of various activities and co-ordination with Cross Functional Teams for procurement of API, excipients, equipment/instruments for the developmental activities

- Review and approval of various documents like Product Development Report, and other Scientific Reports like Hold Time Study Report, Material Compatibility Study Report, Filter

Compatibility Report, Reconstitution Study Report, MMRs, MPRs, Stability Protocols and Reports

- To evaluate proposed changes in product, process or equipment and ensure that appropriate validations are done.

- To assist in the investigation of batch failures, Preparation of risk assessment, market complaints and product recalls.

- To ensure that the required initial and continue training of concern personnel are carried out.

- Coordinating with various departments like Purchase (SCM), Analytical Development,Production, Regulatory Affairs, Quality Assurance etc.

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