Walk-in || Quality Assurance Validation Officer At Abaris Healthcare
Time and Venue
- 2nd May – 8th May , 9.30 AM – 3.00 PM
- Abaris Healthcare Pvt Ltd Survey No: 2458/001, 2458/002, 2458/003 Untva Rajpur Dharpura Road, AT & Post: Rajpur Patiya, Ahmedabad – Mehsana Highway, Near Hotel Kalapi, Ta: Kadi, Dist: Mehsana
- Contact – Rachna Solanki ( 8980028731 )
Job Description Process Validation Executive
1. Process Validation Planning
- Prepare Annual Validation Master Plan (VMP).
- Develop Process Validation Protocols for:
- New products
- Revalidation
- Scale-up batches
- Technology transfer batches
- Review BMR/BPR before validation batch execution.
- Ensure risk assessment (QRM) before validation study.
2. Execution of Process Validation (Injectable / LVP Specific)
A. Solution Preparation Stage
- Validate mixing time, temperature, and order of addition.
- Monitor critical parameters: pH, Osmolality, Assay, Bioburden
B. Filtration Process
- Validate: Filter integrity (Pre & Post), Bubble point test, Differential pressure
- Ensure proper documentation of sterile filtration.
C. Filling & Sealing Process
- Validate filling volume accuracy.
- Perform media fill coordination with aseptic team.
- Verify line clearance and in-process controls.
D. Terminal Sterilization (Critical for LVP)
- Validate:
- Autoclave cycle
- F calculation
- Temperature mapping
- Biological indicators
- Ensure sterilization load configuration validation.
3. Continued Process Verification (CPV)
- Monitor ongoing batch trends.
- Perform statistical evaluation of:
- Yield
- Rejections
- Sterility results
- Environmental monitoring data
- Identify process drift and initiate CAPA if required.
4. Risk Assessment & QRM
- Perform risk assessment as per ICH Q9.
- Identify Critical Process Parameters (CPP).
- Identify Critical Quality Attributes (CQA).
- Establish control strategy.
5. Documentation & Reporting
- Prepare:
- Validation Protocols
- Validation Reports
- Summary Reports
- Risk Assessment documents
- Ensure timely closure of deviations during validation.
- Maintain validation tracker.
6. Regulatory & Audit Compliance
- Present validation data during:
- Regulatory audits (WHO / USFDA / MHRA)
- Customer audits
- Maintain readiness of:
- VMP
- Sterilization validation files
- Media fill records
- Trend reports
- Address audit observations related to validation.
7. Cross-Functional Coordination
- Coordinate with:
- Production
- Engineering
- QC & Microbiology
- Maintenance
- Ensure proper sampling and testing during validation batches.