Skill: validation , capa , quality management , regulatory audits , vendor audit; Exp: 0-3 years; 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 validation of the Critical utilities like 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 audit, providing timely effective response for the same. Timeline conscious in delivering the requirements Experience in API/QC/Development lab facility is preferred. Expertise in 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. Education qualification might be with BE in computer Science or MSC in CS or M Pharm or equivalent having experience of Qualifications and requalification of Equipment/Facility/Systems, critical utilities like 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 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.
Function: Quality / Process Control