- 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 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 behaviours.
- 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.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Senior
Employment Type: Permanent Job, Full Time
Alkem Laboratories Ltd
Established in 1973 and headquartered in Mumbai, India, Alkem began operations as a healthcare marketing company. Today, Alkem is a significant player in the branded drugs and generic drugs space and has a wide ranging presence across acute and chronic therapeutic segments. Its increasing market share can be seen in segments such as Anti-infective, Gastro-intestinal, Pain Management, Vitamins/ Minerals/ Nutrition, Central Nervous System, Anti-diabetic, Anti-osteoporosis, Anti-malarial, Cardiovascular, Immunosuppressants, and Nutraceutical.
We have developed a portfolio of 736 branded generic drugs and command market leadership with 13 of our brands featuring among the top 300 brands in India for the fiscal year 2015. We have 16 manufacturing facilities, fourteen in India and two in US. Five of our facilities are US FDA, TGA, UK MHRA approved. At Alkem, we produce branded generics, generic drugs, active pharmaceutical ingredient and Nutraceuticals which are not only marketed in India but also in 55 countries, internationally.