Prashant Patil Email & Phone Number

Kalyan Dombivli, Maharashtra, India

Nashik

Responsible for QA and RA functions, Set and maintain QMS. Preparation of DMF, protocols, SOPs. Perform validations and Qualifications. Licensing.

Vikramgad, Thane

Leading QA & QC section& accountable for all quality related activities like vendor approvals, OOS, change controls, deviations, recalls, regulatory compliance etc. Responsible for maintaining ISO/GMP/USFDA/EU in unit. Assisting in formulating operational strategies for the quality function, carry out long term and short term quality planning in line with the organization & regulatory requirements. Adhering to the various quality measures and functioning as an instrumental member for the implementation of QC methods and handling & investigation of Customer queries / complaints and returned goods. o Monitoring the performance of the team activities carried out as per GLP & GDP, reviewing of reports, carrying out activities as per SOP's also, preparing SOP’s, review and work in accordance with the Technical agreement with the Customers. A key player along with development team lead conduct feasibility assessment for manufacture of new/modified product and/or process change also, provide necessary feedback to technical team management. Liaising between process development group and production team, developing, implementing and executing technology transfer plan for new/modified product or process on the shop floor maintaining original product performance attributes also, generating relevant reports and maintains necessary records. Defining operational parameters and ensure strict adherence thereto to generate maximum operational efficiency, with the production and development team, evaluate, study critical check points about product making/materials handling with documentation.

Boisar

Responsible for controlling the production process of the products required and fulfilling the requirements raised by the marketing department. Ensure smooth running of the department and maximum utility of available resources in all departments thereby increasing efficiency & production and reducing wastages. Safeguarded that the manufacturing equipment are in order and functioning properly; organize for repair in case of defect without hampering production target. Accountable for maintaining sufficient raw and packing materials for the product in progress and organizing for more supplies in case they are not sufficient in advance. Effectively controlled the wastages of material during processing so as to maintain/improve the yield of products as shop floor. Meticulously maintained the general discipline in the department and on job training of Supervisors, Officers and Workmen’s

Boisar

Responsible for complete operations allied with production; supervised and ensured process settings, quality specifications along with production planning aimed at target achievement. Prepared & reviewed SOP’s & documentation as per WHO, cGMP requirements, engaged in performance monitoring of all key elements of materials management including taking corrective action wherever appropriate. Supervised, planned and executed production operations and process activities; undertook ideal resource deployment, machine scheduling, man power planning and work delegation to achieve set production targets. Reviewed and insisted on S.O.P.s, Quality standards, guidelines and other good manufacturing practices; initiated corrective actions on deviations observed. Communicated all critical information on process / quality to relevant team members to guarantee product quality; conducted online operation checks, entries in BMR at regular intervals and update all process records. Evaluated and updated guidelines and statutory requirements on a periodic basis. Made corresponding adjustments or incorporations in product formula/ process flow as applicable. Complied with the policies & procedures, guidelines relating to hospital pharmacy manufacturing practice, the therapeutic goods administration's code of good manufacturing practice, occupational health, welfare & safety requirements & professional standards.

Boisar

Active participation as Asst Manager QA getting approval of USFDA and EDQM inspections. Prepared total documentation for production, warehouse and HR department starting from level zero. Prepared EDMF independently to get approval of 33 EU nations

Set QMS to achieve ISO 9001-2000 certification. Worked for multideciplines like QMS documentation, management information, solvent recovery project head and dispatch activities. Helped my seniors in product development

Master’S Degree, Chemistry

Pgdba, Operations

Activities and Societies: Post graduate diploma in buisiness administartion

Bachelor Of Science - Bs, Chemistry

B. Sc., Chemistry

B. Sc, Chemistry

A Bonafide Student For M.Sc