QA – Process Validation | Gufic Group | Navsari

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Job Overview

  • Date Posted
    September 19, 2022
  • Location (State / UT)
  • Expiration date
  • Experience
    2 Years, 5 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

  • Responsible to prepare process validation and Bulk hold Time Study protocol and report.
  • Responsible for execution and compilation of Process Validation and Bulk hold time study as per protocol.
  • Responsible for maintaining and tracking the Process validation and Product bulk hold time study status
  • Responsible to initiate / check / handle Quality management system documents i.e. Change Control / Deviation / Incident / OOS/ OOT / CAPA.
  • Responsible for preparation of Annual Product Quality Review.
  • Responsible for providing line clearance during various processing stages i.e. Decartoning/Dispensing /Visual inspection/Packaging etc. and to carry out In-process checks of pre-determined process parameters.
  • Responsible for coordination with internal as well as external department personnel.
  • To prepare and review standard operating procedures.
  • Responsible to maintain the document as per cGMP.
  • Responsible for issuance of documents & maintain records.
  • Responsible to provide the documents to the regulatory department.
  • Responsible to execute / compilation any assigned validation activity.
  • Any other responsibility assigned by the In-charge/Head of the department.

Desired Candidate Profile

  • Candidate having a background in Injectable
  • The candidate should be a Versatile
  • Having deep knowledge of Process Validation
Perks and Benefits
  • Medical Benefits Incl. family
  • PF and Gratuity Benefits
  • Accommodation facility for Bachelors

Qualification: B.Pharma, M.Pharma, MS/M.Sc