Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline. With a workforce of more than 16,000, Mylan has attained leading positions in key international markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
Post: Senior Production Manager
Job Description
Capacity Utilization and Augmentation:
Evaluate current capacities and utilization rates against the business requirements; Review the tentative production plan for respective blocks prepared by the concerned block heads and share with Production Head for review; Provide inputs for the preparation of operational/ revenue/ manpower budgets and capacity augmentation.
Production Execution and Monitoring:
Monitor the implementation of monthly/ short-term/ long-term production plan for respective blocks on the basis of production plan by following the defined procedure; Review production and delivery plans on regular basis with the team members; Resolve/ escalate concerns (OOS, OOT, RM issues) in discussion with respective/ concerned departments; Participate in verification of compliance of different production processes to relevant statutory and regulatory guidelines and design of risk-mitigation plans along with cross functional teams; Provide inputs for preparation of MIS reports; Review and approve batch manufacturing record (BPCR / BPR) and SOP's.
Operational Excellence:
Participate to gather inputs from different teams such as R&D, Quality, Regulatory Affairs, SCM, TSD, EHS as required for implementation of improvement initiatives; Monitor the implementation of identified improvement initiatives with respect to cost, quality and productivity.
Audits and Compliance:
Participate in audit processes with plant production and cross functional teams for relevant audits; Participate in discussions related to compliance/ observations from all relevant audits; Monitor the implementation of CAPA, as committed.
New Product Development and Launch Support:
Follow up with plant teams for timely manufacturing of exhibit/ validation batches along with R&D team; Participate in assessment of resource requirement for scale-up in co-ordination with TSD/ R&D and propose changes/ modifications to ease scale-up requirements; Monitor and review timely execution of exhibit, pre-validation, validation and launch batches; Share inputs with Production Head for commercialization of product developed based on validation/ exhibit batches.
Candidate Profile:
B.Pharm, M.Pharm
Experience : minimum of 9 years of experience with exposure to formulation manufacturing with minimum of 5 years of prior experience in pharma industry for regulated markets.
Knowledge of production technologies and quality systems
Knowledge of regulatory and GMP guidelines
Knowledge of EHS requirements
If you meet the above selection criteria and wish to be a part of our dynamic team, please forward your resume with your contact number and email address to sushmitha.kavuru@mylan.in
Additional Information:
Experience: min. 9 years
Location: Nashik
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 30th jul, 2012
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