Skill: validation , capa , system validation , process validation , quality management , regulatory audits , vendor audit , cleaning validation; 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, facilities and process & other areas 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.
Function: Quality / Process Control