Roles and Responsibilities
JOB SUMMARY: -
Ontime completion of testing and product compliance with respect to regulatory requirements.
Reports to Deputy Manager QC
ESSENTIAL DUTIES: -
- Responsible for completing testing in laboratory
- Responsible for providing support to Global Quality projects
- Responsible for internal QC Audit with respect to GLP requirement
- Responsible for clearance of FG and RM
- Responsible for analyzing and interpreting data
- Responsible for making sure that data is accurately recorded in accordance with guidelines
- Responsible for reporting, trending and presenting results
- Responsible for developing new analytical methods
- Responsible for analytical test method validations.
- 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 conducting/facilitating internal and external audits
- 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 to adhere to the HSE policies of the company.
- Responsible to adhere to the Company Policies and Procedures
- Responsible for participating in the training and upskilling activities
MINIMUM QUALIFICATION REQUIREMENTS: -
- Bachelor's Degree in Pharmacy/Masters Degree in Pharmacy (Pharmaceutical Analysis/Pharmaceutics/Pharmaceutical Chemistry) / Master’s Degree in Chemistry
- Minimum 2 years of experience in Testing in the pharmaceutical or medical device industry.
- Capable to handle instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR etc)
- Sound knowledge on different types of testing/ processes carried out for pharmaceutical/medical products.
- Knowledge on quality standards esp ISO9001:2015 and ISO13485:2016, risk management, Sampling
- Expertise in data analysis using QC tools
- Able to understand and identify key objectives across the business
- Able to deal with multiple issues, tasks and priorities concurrently
- Knowledge about blood bags and applications
- Have strong communication skills complimented with right technical skills to drive meaningful discussions.
Terumo BCT's Core competencies
(Candidate should have the following 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
- Care- Empathy towards people who use our services, team members and customers
- Respect- Should show respect and appreciation toward associates, customers, and business partners.
Additional Requirements (Preferable)
- Previously endorsed as an analytical chemist in pharmaceutical or medical device industry licensed as per Drugs and Cosmetics act 1940
PHYSICAL & TRAVEL REQUIREMENTS: -
- Need to travel to across INDIA and abroad based on the requirement
Role:Engineering & Manufacturing - Other
Salary: Not Disclosed by Recruiter
Industry:Medical Devices & Equipment
Functional Area:Research & Development
Role Category:Engineering & Manufacturing
Employment Type:Full Time, Permanent
UG:B.Pharma in Any Specialization
PG:MS/M.Sc(Science) in Chemistry,M.Pharma in Pharmacy
Terumo Penpol Pvt Ltd
Terumo Penpol Limited (TPL) is India's largest blood bag manufacturer and is a subsidiary of Terumo Corp., Japan. It is also the largest producers of blood bags in Asia, outside Japan. With Quality First ” approach in manufacturing, Terumo Penpol has been serving Blood Centers across the globe for more than 35 years. Partnering with Terumo Corporation, Japan, a global leader in healthcare products, has enabled Terumo Penpol to harness the combined strengths in Technology and Manufacturing to continue redefining standards in Blood Transfusion.
For More Details : https://www.terumopenpol.com/