Senior Executive

4 weeks ago

thiruvananthapuram, India Terumo BCT Full time

Senior Executive QC (Chemical)

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 product. 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 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 equipement 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 Testing laboratory of pharmaceutical industry. Technical Experience/knowledge and Skills required in below. Knowledge on instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR/Vitek 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.


Job Segment: Pharmaceutical, Chemical Research, Lean Six Sigma, Six Sigma, Pharmacy, Science, Engineering, Management, Healthcare

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