Lab In charge QC

Erawat Pharma Limited; Pithampur; On-site; INR 350,000 - 550,000; Full time

Job summary

Erawat Pharma Limited in Pithampur is seeking a QC professional to regularize QC activities per CGMP, ensure regulatory and pharmacopoeia compliance, and review hybrid and electronic data for IPCC and FG analysis.

You will perform analytical method validation (OOS/OOT), operate QC instruments (HPLC, UV-Vis, ICP, melting point), and plan validations such as process, cleaning, water, HVAC, and environmental validation.

Qualifications

• Knowledge of CGMP and regulatory requirements for lab compliance.
• Familiarity with data integrity and regulatory guidelines (21 CFR Part 11).

Responsibilities

• Regularize the QC activity as per cgmp requirements
• Regulatory and Pharmacopoeia requirements for lab compliance
• Review of hybrid and electronic data for IPCC and FG analysis
• Analytical method validation, OOS & OOT.
• Knowledge about IMS system ( ISO 9001: 2015, ISO 14001: 2015 OHSAS 18001 : 2007, and cgmp .
• Analytical skills for QC instrument, that is HPLC UV- Visible, DT instrument, ICP, K / F, melting point etc.
• Planning and execution of validation like process validation, cleaning validation, water validation HVAC validation and environment validation etc.
• Coordination with QC staff, R&D, commercial and production for quality and dispatch related activities for on time dispatches.
• Resolve the trouble shooting related QC activities.
• Training to subordinate and employee of 21 CFR Part 211, with Data integrity (part-11 )compliance in lab.
• Awareness about responsibilities care (Environment health, safety and security).

Tools

HPLC

UV-Visible

ICP

Melting Point

Job description

1. Regularize the QC activity as per cgmp requirements

2. Regulatory and Pharmacopoeia requirements for lab compliance

3. Review of hybrid and electronic data for IPCC and FG analysis

4. Analytical method validation, OOS & OOT.

5. Knowledge about IMS system ( ISO 9001: 2015, ISO 14001: 2015 OHSAS 18001 : 2007, and cgmp .

6. Analytical skills for QC instrument, that is HPLC UV- Visible, DT instrument, ICP, K / F, melting point etc.

7. Planning and execution of validation like process validation, cleaning validation, water validation HVAC validation and environment validation etc.

8. Coordination with QC staff, R&D, commercial and production for quality and dispatch related activities for on time dispatches.

9. Resolve the trouble shooting related QC activities.

10. Training to subordinate and employee of 21 CFR Part 211, with Data integrity (part-11 )compliance in lab.

11. Awareness about responsibilities care (Environment health, safety and security).