To carry out Quality assurance and development activity in the field of Organic Chemistry, to make profit for the organization, motivate, guide & lead a team of scientists, Direct strategic planning and the development of goals allied with organization objectives for the Quality group. Ensure the development of talent for leadership roles and plan talent succession for Quality Specialty Operations. Key focuses on maintaining State Of Control, Quality, Compliance, robust and efficient service level and continues improvement.Recommend actions or policies that result in quality operational sites enhancements for compliance and inspection readiness, ensure that critical or strategic priorities at the regional sites are adhering to global quality policies and that sufficient quality oversight is demonstrated in all operational deliverables. Acting as Quality Program Lead for assigning projects to ensure appropriate quality of development and production within defined timelines. Representing Quality Operations in cross-functional project teams with responsibility for oversight of the overall quality of the project .Co-ordinate with inter department functions and manufacturing site functions for technical evaluations and review wherever required.
Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes Laboratory Process optimization, Operational Excellence, analytical excellence, compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum and other GMP system etc.). Up date knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial products.Hands-on expertise in highest quality standards, GMP compliance and build a quality orientated culture.and worked in regulated plants having approvals of US FDA, MHRA.etc.Hands-on experience in successfully handling and implementing cGMP (Current Good Manufacturing Practice) practices, quality management system, risk assessment, mitigation and Good Documentation Practices

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Interests:

: To carry out research and development activity in the field of Organic Chemistry, to make profit for the organization, motivate, guide & lead a team of scientists, conduct literature search, identify and execute new/novel routes for the synthesis, scale up from grams to kilo levels in lab., conduct pilot trials and assist in production upto ton levels. Carry out impurity profiles and assist in dossier writing. All the above being done keeping in mind the regulatory, safety, environmental issues. To keep in mind IPR issues and draft patents , Commercial aspects taken care are the time schedules, quality parameters and cost factors. All this with a view of non infringement and confidentiality. Simultaneously develop business acumen and convert to profits.file DMFS in US and EU, file patents and contribute to intellectual property

Field/Industry: CHEMICAL/PHARMA

Occupation/Role(s): HEAD

Organisation(s):

IPL LTD

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Non-Information Resource URI: http://www.myexperiment.org/users/57553

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