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Senior Manager

3.00 to 5.00 Years   Chennai   26 Apr, 2020
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / TaxSales / BD
EmploymentTypeFull-time

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 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.
,

Keyskills :
sap is21 cfr salesrisk management tools risk managementmis accountancyquality management system

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