Zydus Hospira Oncology Private Limited (ZHOPL) is looking for B.Pharma candidates for the following post of SENIOR EXECUTIVE – QUALITY ASSURANCE (VALIDATION).
Zydus Hospira Oncology Private Limited (ZHOPL) is a 50-50 % joint venture (JV) company between Zydus Cadila Healthcare Limited (CHL), 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 the long term and A1+ for the short term by CRISIL.
Title: SENIOR EXECUTIVE – QUALITY ASSURANCE (VALIDATION)
Experience: 3 to 5 years
Salary: INR 3,00,000 – 4,00,000 PA.
Skills: Validation, Cleaning Validation, process validation, QMS, Equipment Qualification, Quality Assurance, Equipment Validation
- Preparation and review of Change control
- Deviation related to qualification
- SOP preparation
- Review of risk assessment GAP assessment
- Back up support in audit
- Preparation of Monthly management review slide for validation department
- Providing qualification data for submission purpose
Periodic review and System policy management
New Equipment qualification activity
- Conducting FAT of new equipment
- Review of Design qualification and related document provided by supplier
- Preparation and execution of IQ/OQ/PQ of new equipment
- Inclusion of equipment in GMP system
Software qualification execution
Requalification execution of:
- Aseptic Process Validation by Media Fill Activities.
- HVAC Qualification and Validation.
- Autoclave Validation.
- SIP Validation Mixing vessel, Holding vessel, and Filling machine.
- Terminal sterilization
- De-hydrogenation Tunnel Validation
- Vial Washing Machine Validation
- Freeze Dryer Validation
- Facility Qualification
- Water System Validation
- Validation of various utilities equipment like Air compressor, Nitrogen plant, Pure steam generator (PSG), Multi-column distillation plant.
- Quality Control instrument re-qualification
- Qualification of various Quality control department equipment like Incubators, Walk-in stability chambers, Hot air oven, and other instruments.
- Area qualification
- Handling of various temperature data logging devices like Kaye validator, G-Tek, Temperature and Relative humidity data logger of Testo and Escort Make.
Requalification schedule preparation
Process and Cleaning validation
- Process Validation of different product for proposed changes i.e. Batch size change, API
- New product assessment
- Process validation of Cordon transfer product
- Cleaning validation of new product and routine cleaning validation as per schedule