Terumo BCT Pharma & Chemistry Job, Apply Online
Senior Executive – QC
Date: Jan 1, 2025
Location: Thiruvananthapuram, KL, IN
Company: Terumo BCT, Inc.
Sr. Executive QC (Microbiology)
JOB SUMMARY: Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines.
REPORTING: Reports to Assistant Manager QC / Deputy Manager QC
ESSENTIAL DUTIES:
Administration/Internal Communications:
- Responsible for completing testing as part of Chemical, Functional, 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.
Other duties and responsibilities:
- Responsible for analysis and inspection of raw materials, accessory items, and finished products.
- 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 comply with 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, and 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) or Master’s Degree in Microbiology.
Experience:
- 5 to 7 years of experience in the testing laboratory of the pharmaceutical industry.
- Technical experience/knowledge and skills required:
- Knowledge of instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/Vitek, etc.).
- Knowledge of Microbiological testing (Environmental monitoring, Sterility test, Microbial identification, Microbial Enumeration, Bacterial Endotoxin Testing, etc.).
- Knowledge of performing tests as per Pharmacopoeial requirements (USP/IP/EP).
- Data Integrity.
- Knowledge of different types of chemical analysis.
- Ability to understand and identify key objectives across the business.
- Ability to deal with multiple issues, tasks, and priorities concurrently.
- Knowledge about Analytical/Microbiological tests and Equipment Qualification.
- Preferable to have knowledge about USFDA/EuGMP requirements.
Additional Requirements:
- Capable of working in all shifts, including all three shifts (Night Shift on requirement).
- Strong communication skills complimented with technical skills to drive meaningful discussions.
Terumo BCT’s Core Competencies:
- Integrity: Responsible for life and health; should have a sense of mission.
- Quality: Responsible for safety and quality at all stages of manufacturing; should have a Gemba perspective.
- Creativity: Capable of taking up challenges for the future and working with passion.
Certificates, Licenses, Registrations:
- Preferable for those with endorsement as Analytical Chemist/Microbiologist with State or Central Drugs Control Department.
PHYSICAL & TRAVEL REQUIREMENTS:
- Need to travel across INDIA based on the requirement.
Link to apply: APPLY ONLINE HERE
Keywords: Terumo BCT, Pharma and Chemistry, Senior Executive QC, Job Posting, Thiruvananthapuram. Terumo BCT Pharma & Chemistry Job, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
