Senior Executive QC

4 weeks ago

Thiruvananthapuram, India Terumo Blood and Cell Technologies Full time

Role & responsibilities

  • Responsible for completing testing as part of Microbiological and incoming inspection. Responsible for Document Review and Approval
  • Responsible for providing support to Global Quality projects.
  • Responsible for providing support to complete gap assessments.
  • Responsible for Analysis and inspection of raw materials, accessory items and finished product. Responsible for Document and Test Report Reviews and Approval
  • Responsible for In-process Testing and water testing.
  • Responsible for Microbiological testing (Sterility/BET/Microbial Enumeration/Clean room monitoring)
  • Responsible for making sure that data is accurately recorded in accordance with guidelines.
    • Responsible for reporting, trending, and presenting results.
  • Responsible for Calibration of Glassware and Instruments.
  • Responsible for ensuring products are complying to the established regulatory guidelines with respect to product compliance.
  • Responsible for ensuring GLP and cGDP requirements are in place.
  • Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects.
  • Responsible for empowering people by giving required training
  • Responsible for qualification of analytical instruments and QC equipment
  • Responsible for New product evaluation and stability studies.
  • Responsible for Monthly trending of test results.
  • Responsible for subcontractor training and audits.

Preferred candidate profile

Experience:

  • Not less than 7 years of experience in Testing laboratory of pharmaceutical industry.

  • Technical Experience/knowledge and Skills required as below.

  • Knowledge on instrumental analysis (Vitek, LPC etc)

  • Knowledge on Microbiological testing (Environmental monitoring, Sterility test, Microbial identification, Microbial Enumeration, Bacterial Endotoxin Testing etc).
  • Knowledge on performing test as per Pharmacopoeial requirements (USP/IP/EP)
  • Data Integrity o Knowledge on different type of chemical analysis o Able to understand and identify key objectives across the business.
  • Able to deal with multiple issues, tasks and priorities concurrently.
  • Knowledge about Analytical/Microbiological test and Equipment Qualification
  • Preferable to have Knowledge about USFDA/EuGMP requirements.

Additional Requirements

  • Capable to work in all shifts including All three shifts (Night Shift on requirement).
  • Have strong communication skills complimented with right technical skills to drive meaningful discussions

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