Sr Executive - Microbiology

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

JOB SUMMARY: -

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.

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.