Officer – Process Validation Post @ Otsuka Pharma

0
99

Otsuka Pharmaceutical India Pvt Ltd.

Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, India, for Infusion Business in India and Emerging Markets. We primarily manufacture & market products across multiple markets and therapeutic segments. Being a leader in intravenous nutrition products, we are committed to being the best partner of patients and healthcare professionals in the field of clinical nutrition.
In order to keep pace with our growth plan we required candidate with a sound experience in Quality Assurance – Process Validation mainly into Parenteral / injectable.

Job Title:    Officer / Sr. Officer

Job Description:

Brief Job description as per below.
  • To execute and review PV protocols.
  • To coordinate with all departments for execution of PV activities & to inform Sub-department Manager regarding any deviation from planning.
  • To prepare calendars for yearly activity.
  • To prepare protocol for PV with Sub-department Manager and send it for approval one month in advance and plan for execution with Production Planning Availability (PPA) and Production Departments.
  • To review process validation, qualification planner & send it to Sub-department Manager for further review & information.
  • To ensure implementation of validation, qualification activities.
  • To ensure observation sheets for process validation are duly filled & signed.
  • To coordinate among various departments for process validation, qualification activities.
  • To conduct Material issuance for validations.
  • To conduct Sample withdrawing during process validation on time & online.
  • To conduct training before execution of validation & reviewed performance of qualification report.
  • To conduct new equipment qualification & validation and get it reviewed by Sub-department Manager.
  • To collect data & compile report for preparation of Change Control Note (CCN), Deviations International Regulatory Affairs (IRA)/ Regulatory / Queries / Compliances / Submissions / In-Process Quality Assurance (IPQA) data / Corporate Quality Assurance (CQA) and to do submissions.
  • To Train the subordinates on various aspects of Good Manufacturing Practice (GMP) etc.
  • To contribute team spirit & guide the team starting from preparation, planning & execution & till the preparation of validation report.
  • To include new concept in validation from new guidelines or from regulatory agency to improve the validation.
  • To keep the facility updated from GMP aspect as per regulatory expectation.
  • To ensure that all Calibrations are performed as per the Calibration Manual.

Apply Online

LEAVE A REPLY

Please enter your comment!
Please enter your name here