Senior Executive - QC

Terumo Blood and Cell Technologies


Date: 1 week ago
City: Thiruvananthapuram, Kerala
Contract type: Full time
Title of Associate: - Sr. Executive QC (Functional)

JOB SUMMARY: -

Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines.

REPORTING: -

Reports to Functional lab in charge QC

ESSENTIAL DUTIES: -

Administration/Internal Communications:

  • Responsible for completing testing as part of Chemical, Functional 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.

Other Duties And Responsibilities

  • 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 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.

MINIMUM QUALIFICATION REQUIREMENTS: -

Education:

  • Master’s degree in chemistry or Bachelor's Degree in Pharmacy or Master’s Degree in Pharmacy (Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry)

Experience:

  • 5 to 7 years of experience in Testing laboratory of pharmaceutical industry.
  • Technical Experience/knowledge and Skills required in below.
    • Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/ 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
    • Knowledge on different type of chemical analysis
    • 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.

Terumo BCT's Core competencies

  • Integrity – Responsible for life and health, should have that sense of mission.
  • Quality – Responsible for Safety and quality at all stages of manufacturing should have a Gemba perspective.
  • Creativity- Capable for taking up challenges for the future and work with passion.

Certificates, Licenses, Registrations:

  • Preferable for those who are having endorsement as Analytical Chemist/Microbiologist with State or Central Drugs Control department.

PHYSICAL & TRAVEL REQUIREMENTS: -

Need to travel across INDIA based on the requirement.

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