QC Documentation Specialist

Urgently required candidates for reputed Company 

 🔍Profile: QC Documentation Specialist 

 👨‍🎓Qualification: B.Pharma,M.Pharma               

💵Salary: Up to ₹40,000 per month

Experience -5-6(Should have good experience in a GMP- regulated QC laboratory.                

 Reports to -Quality Control Manager /QA Lead.             

  Industry : Pharmaceutical.      

🛠️ Key Responsibility -

1. Data Integrity & GDP Oversight

Audit Trail Review: Conduct periodic reviews of electronic audit trails from laboratory instruments (e.g., HPLC, GC, UV-Vis) to ensure no data was deleted or manipulated.

Raw Data Verification: Cross-check bench-top notebooks against instrument printouts to ensure manual entries match machine-generated data.

ALCOA+ Compliance: Ensure all documentation is Attributable, Legible, Contemporaneous, Original, and Accurate.

2. Analytical Record Review

Review of Analysis: Technical review of analytical reports for accuracy in calculations, dilutions, and adherence to the Pharmacopoeia (USP/BP/EP).

Stability Documentation: Manage records for stability studies, ensuring pull-dates and testing windows are strictly met.

Reagent/Standard Logs: Maintain and audit logs for the preparation of reagents, volumetric solutions, and the qualification of Working Standards.

3. QMS & Regulatory Documentation

OOS/OOT Coordination: Document and track Out of Specification (OOS) and Out of Trend (OOT) investigations, ensuring they are closed within the mandated 30-day window.

SOP Management: Author and revise Quality Control SOPs and Standard Testing Procedures (STPs).

Change Control: Manage documentation related to changes in analytical methods or laboratory equipment.

🔮Location -Ropar(Punjab) 

 ☎️Call or Refer :9915151975

 📧Email -mettlehrsolutions@gmail.com