Officer/ Sr Officer | QA | Gufic Group | Navsari

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Job Overview

  • Date Posted
    June 29, 2023
  • Location (State / UT)
  • Expiration date
    August 4, 2024
  • Experience
    1 Year, 6 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Roles and Responsibilities

Quality management system
  • Coordinate with the cross-functional department for execution of training planners and maintain training records for same.
  • To master, issue, and retrieve SOPs/BMR/BPR/QC dockets and other documents in line with the laid down procedure.
  • To maintain vendor-related documents and conduct vendor audits.
  • To investigate and prepare a Market Complaint investigation report.
  • To take follow up and communicate with customers/vendors regarding Complaints.
  • To handle Change control/Deviations/Incidents/NCR/CAPA.
  • Review of quality technical agreements.
Process Validation
  • To prepare process validation and Bulk hold Time Study protocol and report.
  • Execution and compilation of Process Validation and Bulk hold time study as per protocol.
  • Preparation of Annual Product Quality Review
  • Responsible for maintaining and tracking the Process validation and Product bulk hold time study
  • Responsible for initiating/checking/handling Quality management system documents i.e. Change Control / Deviation / Incident / OOS/ OOT / CAPA.
Desired Candidate Profile
  • Candidate must have experience in Injectable plant
  • Good Verbal & Written skill
  • Proficient in Ms office/Excel & Word

Qualification: B.Pharma, M.Pharma, MS/M.Sc (Science) in Organic Chemistry