QA Department
Experience: 4-6 years
Qualification: B.Pharm / M. Pharma / M. Sc
Job Responsibilities:
- Injectable Background: Candidate must possess a background in injectable pharmaceuticals.
- Software Knowledge: Proficiency in software such as Lab Solution, Chromeleon & Spectrum is required.
- Instrumentation: Knowledge of instruments including UV, HPLC, FUR, GC, LPC, TOC, Polari meter, and Refractometer is essential.
- SOP & Standard Test Procedures: Responsible for the preparation and review of Standard Operating Procedures and Standard Test Procedures.
- Quality Management: Preparation and review of Impact assessment, trends, OOS/OOT/incidents, Change Control.
- Protocol & Reports: Preparation and review of protocol and reports.
- Analytical Method Transfer: Responsible for analytical method transfer for all developed products covering all analytical parameters as per respective SOPs.
- Analytical Results Review: Review of analytical results in the laboratory.
- Data Review: Responsible for raw data review of various analyses including water analysis, raw material, packaging material, in-process, finished product, stability data, validation data & microbiological data.
- Quality Management Systems: Participation in and investigation of Quality Management System processes such as Change Control, Incident, CAPA.OOS&OOT.
- Control Sample Handling: Handling of control samples.
- Electronic Data Review: Responsible for electronic data review and audit trail-related documents.
- Regulatory Compliance: Knowledge of 21 CFR Part 11.
Job Location: Indore
Interested candidates are requested to send their resumes to hr.indore@guficbio.com.
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