Officer/ Sr Officer | QA | Gufic Group | Navsari

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
Desired Candidate Profile

Candidate must have experience in Injectable plant

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