Assistant Manager – Validation

From 6 to 8 year(s) of experience
₹ 6-10 Lacs P.A.
Posted: 17 days agoOpenings: 1Job Applicants: 206Job Views: 996

Job Description

- Thermal Mapping Like- SIP of mixing and Holding vessel, Steam Sterilizer Autoclave, Terminal sterilization, Depyrogenation Tunnel, Lyophilizer qualification, Filling machine and cold room and area mapping study.

- Media fill simulation study.

- Isolator qualification

- HVAC qualification (Equipment- Pass box, Cytosafety cabinet).

- Process validation.

- Utility qualification (Compressed air, Nitrogen and Steam quality Test)

- Vial washing machine qualification.

- Process knowledge Change control and CAPA

- Protocol, Validation summary report and SOP Preparation.

- Handling of kaye validator.

- Cleaning validation.



Role:Quality Assurance - Other

Salary: 6-10 Lacs P.A.

Industry:Pharmaceutical & Life Sciences

Department:Quality Assurance

Role Category:Quality Assurance - Other

Employment Type:Full Time, Permanent

Education

UG:B.Pharma in Any Specialization

Company Profile

Zydus Hospira Oncology Pvt Ltd.

Zydus Hospira Oncology Private Limited (ZHOPL) is a 50-50 % joint venture (JV) company between Zydus Lifesciences Ltd. (ZLL), India and Hospira Australia Pty. Ltd. A Pfizer Company. The company is the manufacturing base for a defined range of oncology (cancer treatment) formulations, namely cytotoxic injectable. ZHOPL has set up a manufacturing plant in Pharmez (SEZ), Pharma specific SEZ near Ahmedabad. The Company has secured regulatory approvals from global regulatory bodies like the USFDA, MHRA, Health Canada, TGA, ANVISA and so on. This JV Company supplies injectable oncology formulations in the global generic market. ZHOPL has been rated AA-/Stable for long term and A1+ for short term by CRISIL.

Company Info
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Contact Company:Zydus Hospira Oncology Pvt Ltd.

Address:Zydus Hospira Oncology Pvt. Ltd. (JV of Zydus & Hospira a Pfizer company) Plot No. 3, Pharmez-SEZ, N.H. No. 8A, Matoda, Sanand, Dist.: Ahmedabad 382 213 Desk: +91-2717-663114 | brijal.sabalpara@zydushospira.com

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