Senior Executive - QC

Sr. Executive QC (Functional)

JOB SUMMARY: -

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

REPORTING: -

Reports to Deputy Manager 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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