Job Description:
- Should have a reasonable experience in Pharma Production following CGMP guidelines in a Managerial role in oral solid dosage plant producing Tablets / Capsules / Oral Powder
- Experience in handling entire production process right from Planning to Execution.
- Accountable for production, productivity, quality of process & products.
- Monitor, control and correct all critical parameters at all stages of production.
- Ensure proper utilization of resources, and should be sound in men and material planning
- 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 final yield of the product.
- Should have experience of facing plant audits by companies, local/international authorities.
- Handling and Exposure of facing Audits such as: - WHO-GMP , PIC/s , EU-GMP etc.
- Manage process machineries/equipments and 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.
- Adherence to 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, BMRs, BPRs, Stability Protocols and Reports.
- Coordinating with various departments like Purchase (SCM), Analytical Development, Production, Regulatory Affairs, Quality Assurance etc.
Industry Preferred: Pharma company only in pharma formulation of oral Solids Tablets / Capsules
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