Kevin Patel

Experience

• 

  Meridian Enterprise Pvt.Ltd.

  May 2013 - Apr 2016

  Quality Assurance Officer

  • Documentation as per regulatory requirements.• To prepare, review, authorize, issue and control various documents and Standard Operating Procedures and to approve all Specifications, Standard Test Procedures, Validation, Qualification protocol and reports.• To review Batch Manufacturing Records, Batch Packing Records and to give release of Finished Products for distribution and sale.• To handling regulatory and external audits and compliances.• To conduct and co-ordinate regular Self Inspection programme and compile the CAPA.• To ensure that in-process quality control checks are performed and documented to ensure the quality of products at each and every level.• To retain the samples of raw materials and finished products.• To co-ordinate with Quality control for real time and accelerated Stability testing of finished products.• To handle, investigate and reply to the market complaints.• To co-ordinate, conduct and assess the regular in-house and external training to all the employees.• To perform annual product reviews.• To carry any other responsibility as given by seniors.• To approve all the major, minor changes in the established quality management system.• To Review and approval of various Validation protocols and reports.• Reviewing Analytical method development and method validation and method transfer for drug substances, drug product and cleaning traces samples.• Investigation, reviewing reports and release of finished product, semi-finished product, stability sample, Raw material, Process Validation sample, packaging material, and water sample according to BP, USP, ph Eur. and in-house procedures as per cGLP and cGMP requirements.• Preparation and up gradation of Standard Operating Procedures using change control system. • Preparation of Specifications and Standard Test Procedures for raw material, packaging material, finished product. Show less

• 

  USV PRIVATE LIMITED

  Apr 2016 - Oct 2017

  Quality Assurance Officer
• 

  OLIVE HEALTHCARE LIMITED

  Oct 2017 - Jun 2019

  Quality Assurance Officer
• 

  J.B.Chemicals & Pharmaceuticals Limited(Unique)

  Jun 2019 - now

  Quality Assurance Officer