Ensures that goods and products are processed efficiently, with respect to quality, quantity, planning, cost, HSE requirements and regulations. Manages the resources, the planning, ensures the coordination and the control of a production department in a site or a production unit .
To contribute in the definition and execution of the site strategy and is in charge of implementing Operational Excellence standards (e.g : lean program). He plays a critical role in fostering motivation and excellence in his teams.
Central coordination of production activities and staff. Assurance that products are manufactured according to current GMP standards along with SOPs and BMRs. Assurance that documentation is duly executed. Assurance that machines and equipment are qualified and validated and the they remain in a qualified and validated status, including maintenance. Assurance of knowledge and technology transfer. Recruitment and training of staff within his area of responsibility. Responsible for creation and update of SOPs and BMRs. Assurance that all operators are certified for each operation.
Knowledge in sterile liquid injectable formulation activities lines including dispensing, aseptic addition, filtration ,integrity clean in place (CIP),sterilization in place(SIP), Autoclave & Part washer operation.
Should have experience of handling team and train the team for aseptic area behaviors.
Working as per safety guidelines, focus on quality production. Also understand and execute the technology transfer of new solutions and modifications adhering to regulatory compliance requirements.
Work experience of sterile injectable liquid formulation preferably with insulin product.
Work experience of support in aseptic filling activities functions.
Work experience as per cGMP& good in documentation.
Should have compounding/formulation knowledge.
Should be working in Sr. Management position. (AGM & above)
Experience in Visual Inspection activities.
Willing to relocate to Hyderabad