Clonz Biotech was founded in 2010 by an experienced team of recognized leaders in biosimilar research and manufacturing. We operate from Genome Valley, Hyderabad, India to exclusively focus on developing the biosimilar therapeutic monoclonal antibodies (MABs). Developing therapeutic monoclonal antibodies (MABs) are at the heart of our business which is heavily people / knowledge dependent.
Post : QA - Manager
Job Description :
• Ensure cGMP /GLP/GDP/GCP compliance per Clonz Biotech policies and vision.
• Preparation and review of Quality procedures. Policies and Manuals.
• Review of user requirement specification.
• Review of equipment qualification documents like DQ. FAT. SAT. IQ. OQ and PQ.
• Conducting FAT for the respective Equipment at an external facility.
• Ensure the qualification of all the Equipment and Instruments in the facility.
• Monitoring of qualification, calibration and preventive maintenance schedule for equipment and instruments.
• Preparation. Review and Approval of SOPs/STPs/Specif ications.
• Coordinate with the external agency/ vendor for validation & and calibration of all the Equipment and Instruments.
• Handling of all QMS-related procedures like QRM. Change Control. Deviations, and CAPA.
• Review of logbooks .OBPR of Upstream and Downstream processing area.
Candidate Profile
• Master's degree in Life sciences / Pharmacy with around 6-10 years of relevant experience in the pharmaceutical industry, preferably working in Development QA/Analytical/Process. Reviewer role/Quality Assurance in DS or DP manufacturing unit.
• Have a thorough understanding of cGMP. GLP. and ISO standards requirements and the integration of the regulations into working systems in Quality assurance.
• Should possess a fair understanding of Biologies product process and analytical
Additional Information
Experience : 6-10 years
Qualification : Master's degree in Life sciences / Pharmacy
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 30th september 2023
Send your CV to : syamaladevi.kodukula@clonzbio.com ; hr@clonzbio.com
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