Microbiologist

Permanent Position
14 Mar 2017
Expires on 31 Mar 2017

Company Description

US Medical Device MNC

Posted by

Du Yinan (R1657975 16S8408)

Tel

+65 6730 7813/ +65 8233 2996

Email

Job Description

  • Job Purpose
    • This job exists to provide microbiological and chemistry testing services to the production line to support the manufacturing of heart valves
  • Job Responsibilities
    • Perform routine microbial/chemistry testing services using established procedures/ protocols
    • Evaluate and assist in the feasibility, development and implement of critical systems and sterilization equipment. Lead and collaborate with other functional teams in new processes/equipment qualifications
    • Conduct root cause analysis for product/sample failures and Out-of-Specifications (OOS). Recommend and ensure implementation of corrective and preventive actions
    • Ensure that proper laboratory equipment/instrument such as calibration and maintenance of equipment are carried out timely. Ensure adequate chemical inventories/spare/consumables of the equipment/testing
    • Participate in critical systems, sterilization equipment and laboratory equipment validation / revalidation activities. Establish protocols and execution
    • Write, review and update operating procedures and ensure that specifications are in compliance with cGMP (Good manufacturing Practices), Environment and Safety regulations
    • Review trends of Microbial & Chemistry test data
    • Train, mentor and provide guidance to junior level analysts within the department
    • Adhere to all EHS rules, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others as well as prevention of pollution to the environment

Requirements

  • Bachelor of Science (Microbiology or related discipline)
  • Minimum 3 years of direct pharmaceutical or medical device experience
  • Highly motivated and a team player with leadership qualities
  • Strong, analytical problem solving. Must be proactive in achieving results

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