Rajeev Kumar Email & Phone Number

Sungai Petani, Malaysia

 Currently, taking care of Ranbaxy (Malaysia) Sdn. Bhd (a Sun Pharma Company) at Malaysia as Head QA/QC. Responsible for Quality Assurance and Quality Control departments. Develop, process map and maintain the Quality Management System, QMS, (i.e. Personnel, Documentation Control, Customer Complaints, Quality Defects, Deviation and Investigation Management, Product Recall, Local Self-Inspection, Vendor/Service Supplier Audits, Quality and Technical Agreements, Risk Management, Change Control, Annual Product Review and Management Review) and ensure that it is compliance with Sun Pharma’s Global Quality Policies, Global Quality Standards, Global Standard Operating Procedures etc. To upgrade the technical competencies of the QA and QC team by providing them technical trainings, helping the Regulatory affairs department for filing the products, implementation of Global CAPA’s issued by the Corporate Compliance department. Quality Metrics monitoring and evaluation of actions to maintain compliance level at Site to achieve Quality Index, Track & Trend data for metrics. Ensure Productivity and Service level at plant as per established targets. Ensure that all non-compliances and deviations are documented and investigated by identifying root causes, and that the responsible area implements adequate CAPA. Develop program to measure and account for poor Cost of Quality (sales loss due to remediation, recalls, rejected batches, sales penalties due to product not available/not released on time).

Sikkim

 At Sun Pharma Sikkim (India) plant, I was responsible for Quality Assurance and Quality Control functions in the plant and I was leading a team of 143 QA & QC personnel’s. I was leading a team of QA Oversight functions, this team includes Subject Matter experts from various departments i.e. QA, QC, Engineering, Manufacturing, Packing and Warehouse. Co-ordination with Corporate Quality and Corporate Compliance department for effective implementation of Quality Management Systems in the plant. Co-ordination with other departments (Production, Engineering, Warehouse etc) for effective implementation of GMP at shop floor. Co-ordination with Analytical Development Department and Formulation Development Department for improvements in analytical methods and manufacturing processes respectively, to conduct monthly meeting with Formulation Development Deptt and Corporate Quality team for improvements in the manufacturing processes and elimination of product problems.From September 2015 to October 2016, I was given additional responsibility of two plants (Baddi & Batamandi) and one commercial Lab (ATS Lab, Delhi) on adhoc basis as company was going to shut down all these facilities, I was given the responsibilities of transferring the peoples in co-ordination with HR, completion of all the QMS documents (pending deviations, change control etc), liasoning with Drug Regulatory authorities, shifting of all the documents, stability samples and retention samples to other plants etc.

Baddi

• Joined during the setting up of the plant (Plant I) in Jan 2006 and successfully completed the setup of Quality Control laboratory w.r.t the Installation and Qualification of the QC instruments and recruitment of QC Manpower.• Successfully completed all the QC related activities for the setup of QC Laboratory in the new project for Plant II (Year 2009-10), this includes the selection of QC instrument based on the technicality, installation and Qualification of QC instruments and recruitment of QC Manpower.• Got two back to back promotions in first two years after joining. Responsible for the overall Quality Control functions. To co-ordinate with Production Planning team for timely release of the Raw Materials, Finished Products and Packing materials for smooth planning in manufacturing area. To co-ordinate with the R & D team for troubleshooting in the Analytical Methods. To lead the QC team during the internal and external audits. Core team member for ISO14001 and OHSAS 18001