Hiring for Manager - Project &amp Documentation Cell in Mumbai Suburbs, for Exp. 12 - 15 yrs at Unichem Laboratories Ltd.

  • Esteemed client of Orion TrueTech Services India
  • Mumbai, Maharashtra, India
  • May 18, 2018
Full time Pharma, Healthcare & Biotechnology Jobs

Job Description

Job Description:Position: Manager - Project &amp amp amp Documentation Cell Reporting: Plant Head Role: based at our Roha Plant, Maharashtra (This is a API Plant) Minimum Qualification: B. Pharm/ M. Pharm / B.Sc / M.Sc Experience: 12 to 15 years of experience Job Responsibilities: Ensuring Strict adherence to safety and Housekeeping in all manufacturing plants. Co-ordinate in preparation of HAZOP, HIRA, EIA for all the products registered and for the new molecules that are to be introduced. Ensure strict compliance on cGMP requirements with respect to Production. Review and upgradation of existing production SOPs and work systems at its work place with strict implementation. Co-ordinate with all the departments (Quality Assurance, Quality Control, Warehouse, Engineering &amp amp amp PD labs) with respect to projects. Ensuring detail work out of cost effective projects at site. Preparing, reviewing, approving and distributing the instructions for the production of intermediates or APIs according to written procedures. Ensuring that new or when appropriate modified facilities and equipments is qualified. Preparation of Equipment Qualification protocols and performing all types of Equipment Qualifications. Preparation of all documents (initiation of modification form, raising of CCP, concept notes, qualifications) required for implementation of projects. To ensure all validation, Qualification and calibrations and calibrations are done as per schedule and records are maintained To document all changes through change control procedure in consultation with Quality Assurance Department. To conduct Risk analysis of product, system, equipment, item, process as per standard procedure To investigate, record and report to Quality Assurance any problem which may adversely affect the quality of the material / product like damage to containers etc To help in investigations of deviations/OOS/complaint/OOT observed as per standard procedure. To operate the Unichem Quality Management System based on the roles and rights provided in the application Training to executives / operators / production chemist. Identify the training needs for department personnel. Preparing and supporting cGMP audits and inspections. Compliance of all audit findings and implementation for the same (Pharmaceuticals exposure is must, preferably API)