Sr Executive - Microbiology

Terumo Penpol Pvt Limited; Thiruvananthapuram; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Terumo Penpol Pvt Limited in India is seeking a Senior Executive - QC (Microbiology) to ensure timely Bioburden, Environmental Monitoring, Sterility, and related microbiology testing with strict regulatory compliance. You will review and approve documents, support global quality projects, and drive data integrity across testing activities.

The role requires leading calibration, trend analysis, audits, and CAPA management while training staff and coordinating with cross-functional teams to

Qualifications

• Master's in microbiology or Pharmacy-related master's degree.
• 7+ years in a pharmaceutical testing lab.
• Experience with GLP, cGDP and data integrity practices.

Responsibilities

• Perform Bioburden, environmental monitoring, sterility and microbial enumeration testing.
• Review and approve documents and test reports; ensure data integrity.
• Support global quality projects and gap assessments.
• Lead calibration of glassware and instruments; monitor QA metrics.
• Respond to microbiology audits and regulatory commitments.

Skills

Instrument analysis

Microbiological testing

Pharmacopeial requirements

Data integrity

Analytical instruments qualification

USFDA/Eu GMP knowledge

Education

MSc Microbiology

B.Pharm / M.Pharm

Tools

Vitek

Liquid Particle Counter

Kinetic Turbidimeter

Job description

Title of Associate: Senior Executive - QC (Microbiology).

Responsible for ensuring the timely completion of Bioburden, Environmental Monitoring, Sterility Testing, Microbial Enumeration testing, Bacterial Endotoxin Test, analysis, review, and documentation in compliance with applicable regulatory and quality requirements.

JOB SUMMARY: -

REPORTING: -

Reports to Assistant Manager

QC ESSENTIAL DUTIES: -

Administration/Internal Communications:

• Responsible for completing testing as part of 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 equipment


• Responsible for New product evaluation and stability studies.


• Responsible for Monthly trending of test results.


• Responsible for subcontractor training and audits.


• Monitor QC productivity and testing turnaround times.


• Ensure laboratory investigations, OOS, OOT, deviations, and CAPAs are completed effectively and within timelines.


• Ensure compliance with applicable local and global regulatory requirements.

Job Description

• Ensure implementation and maintenance of GLP, cGDP, and Data Integrity practices.


• Lead responses to microbiology-related audit observations and regulatory commitments.


• Ensure microbiology procedures, specifications, and records remain current and compliant.


• Responsible for supporting WCM, Lean, Six Sigma projects, root cause analysis, Productivity projects.


• Responsible for empowering people by giving required training


• Responsible for qualifications in 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:

Masters degree in microbiology or Bachelors degree in pharmacy or Master’s Degree in Pharmacy (Pharmaceutics/Pharmaceutical Microbiology)

Experience:

Not less than 7 years of experience in Testing laboratory of pharmaceutical industry.

Technical Experience/knowledge and Skills required as below

• Knowledge on instrumental analysis (Vitek, Liquid Particle Counter, Kinetic Turbidimeter etc).


• Knowledge on Microbiological testing (Environmental monitoring, Sterility test, Microbial identification, Microbial Enumeration, Bacterial Endotoxin Testing etc).


• Knowledge on performing test as per Pharmacopeial requirements (USP/IP/EP) Data Integrity Knowledge on different types 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


• Preferably to have Knowledge about USFDA/Eu GMP requirements.

Additional Requirements

• Capable to work in all shifts including All three shifts AE, GE, BE (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.