Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines.
REPORTING: -
Reports to Assistant Manager QC.
ESSENTIAL DUTIES: -
Administration/Internal Communications:
- Responsible for completing testing as part of Chemical, Functional and incoming inspection.
- 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 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 Current product evaluation and stability studies.
- Responsible for Monthly trending of test results.
- Responsible for subcontractor training and audits.
MINIMUM QUALIFICATION REQUIREMENTS: -
Education:
- Bachelors degree in pharmacy or masters degree in pharmacy (Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry) or Masters degree in chemistry
Experience:
- 3 to 5 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.
PHYSICAL & TRAVEL REQUIREMENTS: -
- Need to travel across INDIA based on the requirement.