Chemistry Assistant Manager Job Opening Vacancy @ Syngene
Chemistry Assistant Manager Job Opening Vacancy @ Syngene. Career @ Syngene. Msc Chemistry jobs. Check out all the details on the same below:
Job Id: 3475
Job Title: Assistant Manager
Eligibility: Msc Chemistry/ M Pharma\
Experience:
Qualifications and requalification of Equipment/Facility/Systems, critical utilities like a Purified water system, WFI, PSG, Nitrogen and etc followed by conducting the gap analysis for equipment/systems. Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5 and EU Annex 11 guidelines. Expertize in the validation of HVAC installations and validations and exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls/Deviations and CAPA related to equipment and facilities and expertize in carrying out investigations related to equipment and facilities if any
• Calibration document reviews, Expertize in Gap analysis related to Equipment/Facility/Systems and Knowledge in statistical analysis and risk management tools application and exposure to SAP is essential.
• To handle Service provider Audits and FAT, Exposure to Internal Audits, Customer Audits and Regulatory Audits and knowledge in Area Qualification and experience in API/Formulation/Biologics/QC/Viral testing facility is preferred.
Job Description:
- Qualification and re-qualification expertize related to Equipment, Instrument, Facility, and Area
- Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5, ICH Q9 followed by EU Annex 11 related to all computerized systems.
- Expertize in Gap analysis related to Equipment/Facility/Systems
- Expertize in a validation of the Critical utilities like a Purified water system, WFI, PSG, Nitrogen and etc
- Experience in HVAC installations and validations followed by periodic re-validations
- Thorough knowledge in statistical analysis and different tools of risk management application
- Exposure in Temperature mapping activity of specific areas
- Review and evaluation of Change controls, Deviations, and CAPA related to equipment, systems and facilities followed by having good presentation skills in training the CFTs
- Having very good knowledge in preparing SOPs, EOPs, and exposure in review and approval of equipment master list, PM and Calibration planners.
- Expertize in carrying out investigations related to equipment and facilities
- Calibration document reviews and approvals
- Handling of SAP-related activities which includes improvement and troubleshooting plans
- Exposure to Internal Audits, Customer Audits and Regulatory Audits which includes the preparation for the audit, providing a timely effective response for the same.
- Timeline conscious in delivering the requirements
- Experience in API/QC/Development lab facility is preferred.
- Expertise in the best quality management system, preparing, reviewing and approving all the qualification documents, QMS documents, validation documents and any cGMP documents related to Chemical development and other areas
- To be well versed with CAPA, internal audit, vendor audit, and the other cGMP activities.
- To be stationed at Mangalore and travel to Bangalore if needed.
