Multiple Job Openings for Research Associate – Bio Analytical, Officer – Quality Assurance (Validation), Officer/ Executive – Quality Control (MICRO), Title Management Trainee – IPQA
Title: Research Associate – Bio Analytical
Essential Qualification: B. Pharm / M.Pharm
Desired Qualification : M.Pharm
Total Number of years of experience: 4 to 6 years
Preferred Age Group: Between 24 to 28 years
- Analytical method development in biological fluid using LC-MS/MS (such as plasma, serum, urine and blood)
- Method validation for regulatory submission (DCGI, ANVISA, USFDA)
- Clinical study sample analysis
- Preparation of test method, validation report, study report and SOPs 5. Monitoring GLP compliance in laboratory
Organization Zydys Hospira Oncology Pvt. Ltd.
Title: Officer – Quality Assurance (Validation)
Location: Pharmez – SEZ ,Ahmedabad.
Essential Qualification: B.Pharm
Total Number of years of experience: 0-2 years with clarity in concepts of B.Pharm.
Must have a sound knowledge of basic concepts of B.Pharm and cGMP requirements form the Quality Assurance and Regulatory perspective.
Preferred Age Group: Between 20– 26 years
1.To validate various equipment in the plant and processes like mixing, filling, CIP, SIP and sterilization under the guidance of Manager Validation.
2.To get involved in various processes related to validation of Production processes (equipment, process and cleaning validation) and quality control equipment under the guidance of Manager Validation.
3.To help in Preparing Installation Qualification / Operational Qualification / Performance Qualification Protocols of new equipment and Re qualification protocols for existing equipment of the site.
- To do the technical documentation of equipment / process validation in consultation with various department.
- To execute validation protocol of equipment, process, system and facility for Production, Quality control and Engineering.
6 To initiate exception, change control, Deviation and CAPA as and when required and responsible for closure of the same.
- To perform the sampling during mixing, filling, CIP and SIP validation as per predefined schedule and location.
- To Ensure the Implementation of cGMP in all aspects of manufacturing and other processes of Plant.
Organization Cadila Healthcare Limited
Title: Officer/ Executive – Quality Control (MICRO)
Job Summary: Microbiological Analyst
Essential Qualification: B. Sc. In Microbiology /B.Pharm
Desired Qualification : M. Sc. In Microbiology
Total Number of years of experience: 1 to 7 years
Preferred Age Group: Between 22 to 30 years
Area monitoring & trending of data – Air & Surface/Drains
- MLT, Sterility, BET, Bioburden, Microbiological Assay-Analysis
- Process Validations & Hold Time studies
- Method Validations, Verification & Transfer
- Due-on date Stability samples analysis
- Calibrations, Qualification & Validations – Micro Inst/Equip/Area
- Media Fill trails
- Water sampling & analysis
- Growth promotion/ Seal integrity tests
Organization Cadila Healthcare Limited
Title Management Trainee – IPQA
Location: Agiolax Plant – Goa
Job Summary Handling of IPQA activities in shifts
Essential Qualification: B. Sc./ M. Sc
- Desired Qualification : B.Pharm
- Total Number of years of experience: 1 to 2 years
- Preferred Age Group: Between 23 to 32 years
Perform and monitor IPQA activities (Line clearance and on-line checks).
- Review of logbooks maintained at the shop floor.
- Batch record review for end releases.
- Shop floor observations and reporting GMP non-compliances
- To review and revise Standard Operating Procedures.
- Reporting deviation and change control on shop floor.
- Co-ordination and follow-up for the completion of qualification and validation activities
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