Senior Executive Post @ Syngene | Msc chemistry Jobs
Senior Executive Post @ Syngene | Msc chemistry Jobs. Career @ Syngene. Chemistry candidates can apply senior executive post @ Syngene. Check out all the details for the same below:
Job Id: 3151
Job Title: Senior Executive
Eligibility: MSc Chemistry
Job Description:
- Having experience in API plant commissioning and qualification including the CSV requirement
- 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 the 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.