Executive - QC

Terumo Penpol Pvt Limited; Thiruvananthapuram; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Terumo Penpol Pvt Limited seeks an Executive QC to ensure on-time testing, analysis, and documentation in line with regulatory guidelines. The role reports to the Assistant Manager QC and supports quality projects and gap assessments.

Responsibilities include analyzing raw materials, in-process testing, data integrity, calibration of glassware/instruments, and adherence to GLP/cGDP requirements. Shifts may be required to meet production schedules.

Qualifications

• Knowledge of instrumental analysis (Ion chromatography/HPLC/UV/GC/FTIR).
• Experience with microbiological testing and environmental monitoring.
• Experience with pharmacopoeial requirements (USP/IP/EP).
• Data integrity and analytic instrument qualification knowledge.

Responsibilities

• Complete testing as part of Chemical, Functional and incoming inspection.
• Support Global Quality projects and gap assessments.
• Analyze and inspect raw materials, in-process samples and finished products.
• Record data accurately per guidelines; report, trend, and present results.

Skills

Ion chromatography

HPLC

UV

GC

FTIR

Microbiological testing

Education

Bachelor's/Master's in Pharmacy or Master’s in Chemistry

Job description

Title - Executive QC

JOB SUMMARY: -

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 New 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
  • Abletounderstandandidentifykeyobjectivesacrossthebusiness.
  • Abletodealwithmultipleissues,tasksandprioritiesconcurrently.
  • 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.