Job Description

Title of Associate: - Sr. Executive QC (Functional)JOB SUMMARY: -Ontime completion of testing, analysis, and documentation with respect to regulatory guidelines.REPORTING: -Reports to Functional lab in charge QCESSENTIAL 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..

Terumo BCT