Operations Head

Job Description : : Head - Operations Reporting to : Director/ Sr. President - Ops. Place of posting : head Office DENMARK Position : Managing P&L of manufacturing of pharmaceutical unit, its operations, production/ productivity ensuring quality & regulatory affairs. Role & responsibilities : - Managing plant of operations of Oral Solids & Liquids and Parenteral products; Eye drops (ANDA/ Generics & NDDS) areas of finished Pharma Formulations & maintenance of the manufacturing facility. - Ensuring productivity, quality, cost, service and safety targets for the manufacturing units. - Conceptualizing, creating/ modifying, implementing, monitoring, and maintenance, re-view & upgrade operational procedures. - Managing P& L related aspects of SBU of Pharma formulations plant with effective utilization of resources, minimization of the yield loss and processing waste at various stages of manufacturing - Managing operations of formulations, Branded and Generics i.e. Pre filing state/ Exhibit stage at Pilot plant to Commercial Execution with pre validation and validation matrix environment as per US FDA and EU guide lines for the Pre Exhibit cum Exhibit batches at pre filing and Validation matrix at post validation and during commercialization of the ANDA products - Managing regulatory audits of US FDA, UK MHRA, MCC - south Africa, MSF - France, NMA - Romania, TGA - Australia NDA - UGANDA, MCA - Z, NAFDAC, QSM audit by WHO- GENEVA & US FDA Accountability : Position is accountable for : - Timely commissioning of the project as per project plan - Smooth operation of the plant with desired level of quality - Optimum production / productivity of equipment- s, machinery, & Human resources - Cost optimization - Clearance of Regulatory & other quality audits Desired profile : Qualification : B. Pharma/ M. Pharma Experience : Approx. 20 yrs of experience in managing large scale projects from conceptualization to commissioning & plant operations with any of reputed pharmaceutical company Exposure : should have Hands on experience of managing project from conceptualizing to commissioning of a pharmaceutical plant, managing P&L of the running plant, Managing regulatory & audit US FDA, UK MHRA, MCC - south Africa, MSF - France, NMA - Romania, TGA - Australia NDA - UGANDA, MCA - Z, NAFDAC, QSM audit by WHO- GENEVA & US FDA

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