Sr Executive -Microbiology
- Terumo Bct
- 3 - 5 years
- Thiruvananthapuram
- 9 days ago
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Job Description
- Complete testing, analysis, and documentation according to regulatory guidelines.
- Report to Assistant Manager QC and support Global Quality projects.
- Conduct gap assessments and other duties as required.
- Analyze and inspect raw materials, accessory items, and finished products.
- Review and approve documents and test reports.
- Perform in-process testing, water testing, and microbiological testing (sterility, BET, microbial enumeration, clean room monitoring).
- Ensure accurate recording of data and reporting, trending, and presentation of results.
- Calibrate glassware and instruments and ensure compliance with established regulatory guidelines.
- Support WCM, Lean, Six Sigma projects, root cause analysis, productivity projects, and empower people through training.
- Qualify analytical instruments and QC equipment, evaluate new products and stability studies, and conduct monthly trending of test results.
- Train subcontractors and perform audits.
Job Requirements
- Master's Degree in Microbiology or Bachelor's Degree in Pharmacy or Master's Degree in Pharmacy (Pharmaceutical Analysis / Pharmaceutics / Pharmaceutical Chemistry).
- 3 to 5 years of experience in a testing laboratory within the pharmaceutical industry.
- Knowledge of instrumental analysis (Vitek, LPC, etc.) and microbiological testing (environmental monitoring, sterility tests, microbial identification, microbial enumeration, bacterial endotoxin testing).
- Understanding of pharmacopoeial requirements (USP/IP/EP) and data integrity.
- Ability to handle multiple issues, tasks, and priorities concurrently.
- Strong communication skills and technical skills to drive meaningful discussions.
- Capable of working in all shifts, including night shifts when required.
- Preferably have knowledge about USFDA/EuGMP requirements.
- Experience/knowledge and skills in chemical analysis and understanding key business objectives.
- Integrity: Responsible for life and health, with a sense of mission.
- Quality: Responsible for safety and quality at all manufacturing stages, with a Gemba perspective.
- Creativity: Capable of taking on challenges for the future and working with passion.
- Travel across India based on requirements.
Job Classification
Industry: BiotechnologyFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Terumo BctLocation(s): Thiruvananthapuram+ View Contact
Keyskills: bet environmental monitoring lab testing usfda software testing microbiology root cause analysis
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