QA - Qualification and Validation

2 months ago


Remote, India Zydus Group Full time

Department
- FILL AND FINISH QA
- Job posted on
- Feb 09, 2024
- Employment type
- P-P7-Probationer-HO Staff

Name :Krudip Patel

BU : BU TECH-OPS ( FORM.) MFG

Place : Zydus Lifesciences Ltd., Fill Finish (Unit 09)

Contact #:
6358822958

**Basic Details**:
Position : Executive / Sr. Executive

Reports to : QA Head

Department :Fill Finish Quality Assurance

Location : Zydus Lifesciences Ltd., Fill Finish (Unit 09)

No of Posts : 01

**Key Job Description**:
1. Person having exposure to equipment qualification lifecycle (i.e. URS, DQ, IQ, OQ and PQ) and facility design.

2. Validation master plan, Computer system validation and 21 CFR part 11 requirements.

3. Area qualification, qualification of equipment like Autoclave, Washer, depyrogenation tunnel, lyophilizer, filling machine, Water system, HVAC, etc.

3. Person shall be capable to handle Cleaning validation, equipment trail, MACO calculation, etc.

4. Capable to review and assess process validation.

*** Requirements**:
**Qualification** : B.Pharm / M.Pharm / M.Sc

**Total Years of Experience** : 5-8 Years

**Experience in Zydus** : Minimum 2 Years

**Experience / Exposure in**: Injectable Quality Assurance exposure in USFDA audit.

**Copy mark to your HOD and HR


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