Officer/Executive/Sr. Executive- Microbiology

☞ BDR Pharmaceuticals Internationals Pvt. Ltd.

看过: 103

更新日: 06-05-2024

位置: Vadodara / Baroda Gujrat

类别: 制药/化学/生物技术 保健/医疗 药剂师/药剂师代表

行业: Pharmaceutical & Life Sciences

水平: Microbiologist

工作类型: Full Time, Permanent

经验: 2 - 7 years

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工作内容

  • Co-ordination with Quality Assurance & Production for compliance of inputs and products with respect to microbiological parameters.
  • Handling of analysis of BET, Sterility & MLT with method validations.
  • Investigations of failures in environment, water system & quality of product with respect to microbiological parameters.
  • Responsible to investigate incident, deviation, complaints, OOS, OOT, recalls,batch failures, audit observations, reated to GMP concern.
  • Preparation of SOPs, STPs and Validation protocols related to microbiology department.
  • Checking of all day to day microbiological records.
  • Generation of protocol and execution of Method Validations and Other relevant Microbiological Validation.
  • Coordination with Instrumentation, Maintenance, Vendors and Outside parties with respect to the procurement, servicing, qualifications and calibration of various equipment & system related to Microbiology.
  • Review and approval of Environmental & Water quality trends and other batch releasing microbiological parameters (Bacterial Endotoxin, Particulate Matter, Sterility, Total aerobic counts and Microbial Limit tests of water & non-sterile product.
  • Conducting Training program for the new comers & updation of microbiological requirements for the existing Microbiologists & the manufacturing personnel.
  • Validation support for DHS, autoclave, HVAC for manufacturing facilities and microbiology laboratory.
  • Validation supports for Media fill studies.
  • Assurance of consistent operation and performance all microbiological equipment, Instruments & System.
  • To support regulatory affairs for microbiological aspects & document support for regulatory submissions & amendments.
  • Microbiologist qualification

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最后期限: 20-06-2024

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