Executive IPQA

JOB FAMILY: Quality Assurance
LOCATION: Ghaziabad
BAND: JM2
REPORT TO: Head R&D/QA/QC

ROLE OBJECTIVE:
Process compliance in the view of USFDA, WHO-GMP, cGMP guidelines and company standard.

KEY RESPONSIBILITIES:

1. Ensure proper implementation of GMP requirement
2. Production quality evaluation on-line.
3. Batch release based on test result.
4. Process verification and affix the related tags and reports with BMR.
5. Temperature and Humidity verification and counter check.
6. Batch weight verification.
7. Labeling verification and clearance.
8. Stamp checking and approval online.
9. Dispensing quantity and approved tag verification.
10. Line clearance for processes.
11. Terminal inspection.
12. OOS verification and suggest CAPA accordingly.
13. CAPA implementation review and monitoring the effectiveness.
14. Cleaning and sanitation verification.
    

KEY RESULT AREAS:

1. Process deviation reporting and CAPA Implementation
2. Standard process implementation
3. Periodic verification of actual process with standard.
4. Document control in production area

QUALIFICATION & EXPERIENCE:
B. Pharma/M. Sc.  Chemistry   Exp. –  1 to 4 years in Pharma/Herbal/Unani

SPECIAL KNOWLEDGE, SKILL & ATTITUDE:
WHO-GMP, cGMP, GDP & GLP. Computer & good communication skills.

ROLE INTERFACE:
Production dept. , Maintenance dept., QC dept.