Website Zydus Group Ltd
Post Name: Sterility Assurance
Job Description:
Name: Isha Naik
BU: Quality Assurance
Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.
Email ID: Isha.naik@zyduslife.com
Basic Details:
Position Code: 60062953
Designation: Senior Executive
Reports to: Quality-Section Head
Department: Quality Assurance
Location: ZLL-SEZ Oncology Injectable (Alidac)
No of Posts: 01
Role: Senior Executive
Neev Level: 1
Details: Replacement
Key Job Description: (Not more than 5 points in 6 lines)
Job Purpose:
To ensure sterility assurance of aseptic area/ isolator-based aseptic manufacturing operations by implementing, monitoring, and continuously improving contamination control strategies, aseptic practices, and regulatory compliance.
1. Oversight of aseptic area and isolator-based aseptic processing and sterility assurance program.
2. To perform oversight activity during routine production
3. Prepare and review of Aseptic Process Simulation (Media Fill) protocols and reports.
4. Assessment of aseptic interventions.
5. Review of environmental monitoring (viable, non-viable) and trend analysis.
6. Participation in deviation investigations, CAPA, and risk assessments.
7. Prepare and review of CCS (contamination control strategies)
8. Review of smoke study protocol, report and video recording.
9. Review of microbial data deviation
10. Review of executed Aseptic process simulation study (Media fill) BMR.
11. Support regulatory audits and act as sterility assurance SME.
12. Ensure compliance with EU GMP Annex 1, US FDA, and WHO GMP requirements.
13. To participate the regulatory or any external inspection at site.
Qualification: B.pharm/M.Pharm
Years of Experience: 4 to 10 Years
Experience / Exposure in. (2 points) :
4–10 years of experience in sterile pharmaceutical manufacturing. Hands-on experience with isolator systems, media fills, smoke study and environmental monitoring.
Skills and Competencies:
Strong knowledge of aseptic processing, smoke study and contamination control.
Good understanding of regulatory requirements and data integrity.
Strong investigation and root cause analysis skills
Mail your CVs to: isha.naik@zyduslife.com
