Director Aseptic Compliance, Training Materials & Batch Release

About Glenmark Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark Pharmaceuticals Ltd. employs over 16,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil. Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company. Position Summary The Director of Aseptic Compliance and Training is responsible for leading the development of training and certification/qualification programs, delivery of training sessions, and maintenance of ongoing metrics associated with aseptic manufacturing practices at the site. The position is also responsible for ensuring that activities are appropriately tracked in the Learning Management System (LMS). The Director of Aseptic Compliance and Training role will provide technical proficiency and consultative guidance as an aseptic subject matter expert (SME), and must also have the ability to communicate these requirements to trainees who have a broad educational background and experience in microbiological principles. The Director of Aseptic Compliance and Training collaborates with all levels of Aseptic Manufacturing to confirm aseptic training plan objectives are met through effective learning and training solutions. They serve as the site’s POC (Point of Contact) for providing advice concerning enhancements to aseptic practices, certification program and other training related projects. This role also oversees disposition of Raw materials and Finished Products from the Site following applicable site procedures including but not limited to batch record review. Raw material includes API, Excipients, Packaging Materials and Consumables. Responsibilities OVERALL JOB RESPONSIBILITIES Results Expected/ Target Financial Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site Maintain quality system controls to ensure no critical and major market complaints Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency. Operational Excellence Develop the various positions and roles and responsibilities necessary for the Aseptic Compliance and Training Department. Lead the development and implementation of policies and procedure as required to support the day to day activities of the department including periodic evaluation by shop floor oversight. Lead the development and administration of the aseptic behavior certification program for employees working in the manufacturing aseptic environment including operational staff, cleaning staff, microbiology, maintenance staff, etc. Lead the activities required to develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment. Lead efforts to drive continuous process improvement activities with the dual goals of reducing risks of contamination, reducing waste, increasing process efficiency, and reducing safety hazards. Coach and mentor employees on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non- routing interventions. Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing. Assess work environment to ensure it is suitable to enable good aseptic behavior…

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