INDER SINGH BARGALI BARGALI

Experience

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  Avantor Performance Materials India Limited (Formerly known as RFCL Limited)

  Jan 2013 - Aug 2015

  Deputy General Manager-Plant

  1. From Jan 2013 to Aug 2015: Deputy General Manager-Plant, Organization-Avantor Performance Materials India Limited (Formerly known as RFCL Limited).Job Responsibility:1. Provide inputs towards formulation of Plant strategy and create a strategic roadmap for Dehradun plant to deliver organization expectations.2. Formulate and drive achievement of plant plans to deliver its targets.3. Manage relationships with regulatory bodies and internal customers to build a favorable image of Avantor Performance Materials India Limited.4. Ensure technical development of plant resources, systems and processes to drive long term sustainable quality as well as efficiency within plant team.5. Ensure compliance with organizational processes as well as regulatory and statuary requirements.6. Develop a high performance work environment to build a capable and motivated team within Dehradun plant.7. Five direct reportees and 51 indirect reportees.Achievements:1. Successful transition from RFCL Limited to Avantor Performance Materials Limited. 2. Re-certifications of ISO 9001-2008, ISO 14001-2004, ISO 13485-2003. 3. Four new successful technology transfers (Hematology, Biochemistry and Elisa products, Total 10 products).4. Implementation of global standards.5. Uninterrupted plant activities during worker unrest.6. Highest production in a month in the history of the Diagnostics.7. Maintained the capacity to more than 80% in single shift till date. 8. Certified internal trainer and auditor for ISO 9001-2008 and ISO 14001-2004.9. Thorough working knowledge PP, QM, MM and SD SAP module. Show less

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  DPPB Solutions

  Aug 2015 - now

  Auditor, Trainer and Technical Expert for Medical Devices (Speciality in IVD)

  We are a group of diversified, global medical device Regulatory Affair and Quality Management System Consultants focused on developing and delivering best Regulatory Strategy, Quality Management System and Training services for global registration and submission of medical device that meets all major standards and regulations worldwide. We serve many segment of Medical device industry with emphasis on Orthopedic Implant, Internal Prosthesis Replacements, Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Cardiac Stents, Drug Eluting Stents, Catheters, Intra ocular Lances, I.V. Cannulae, Heart Valves and Bone Grafts/Bone Cements, IVD.Medical Device Factory Layout Planning and factory setup service.Manufacturing Licensing consultancy service (In form 28).Import Licensing consultancy service (In form 10).Consultancy for medical device registration and approval in India (In form 41).Quality Systems Implementation service.ISO 13485 and CE Certification consultancy service.Audit preparation, Document preparation and Quality management system Training.Clinical Evaluation and Risk Management.USFDA 510(k) Consulting for Medical Devices.Consultancy for Medical Device Registration in India.Indian authorized agent for medical device companies Show less