Asst. Manager Microbiology

About Syngene:

• Syngene (www.syngeneintl.com
• ) is a pioneering contract research, development, and manufacturing organization delivering integrated scientific services from early discovery through commercial supply.

At Syngene, safety is a core priority embedded in every aspect of our work, with shared responsibility for adhering to safety protocols, guidelines, and SOPs to ensure a safe and compliant work environment.

Safety & Compliance Expectations:

• Ensure strict adherence to safety procedures personally and within your team.
• Support development and implementation of processes that promote safe operations and compliance with Syngenes integrity and quality standards.
• Foster a culture that emphasizes environment, health, and safety (EHS) awareness and discipline throughout the workplace.
• Complete all mandatory training related to data integrity, health, and safety for self and team members on time.
• Take accountability for achieving safety goals and regularly review safety metrics.

Role Overview:

• Perform sterility testing using isolators and conduct Bacterial Endotoxin Testing (BET) with KTA/PTS systems.
• Manage qualification and requalification of microbiology lab equipment and instruments.
• Initiate and investigate Out of Specification (OOS), deviations, change controls, and Corrective and Preventive Actions (CAPA) ensuring timely closure.
• Prepare and review SOPs, specifications, and relevant annexures.
• Conduct microbial analysis of raw materials, finished products, and stability samples following prescribed specifications.
• Support Quality Control Microbiology (QCM) operations including sterilization, media preparation, growth promotion, culture maintenance, media disposal, and environmental monitoring.
• Participate in equipment calibration, validation, cleaning, fumigation, and other lab maintenance activities.
• Maintain records and prepare microbiological trend reports for the facility.
• Plan and schedule analytical activities to meet compliance with SQDECC parameters.
• Undertake additional responsibilities as assigned by the Head of Department or team leader.

Key Responsibilities:

• Perform sterility testing using isolator technology.
• Demonstrate working knowledge of Quality Management Systems (QMS) and Laboratory Information Management Systems (LIMS).
• Support equipment qualification and validation efforts.
• Conduct routine microbiological tests and provide laboratory support.
• Syngene Core Values:
• Excellence
• Integrity
• Professionalism

Candidate Profile:

• Experience:
• 6 to 10 years of relevant experience in microbiology
• Skills and Competencies:
• Strong foundation in microbiological techniques and sterility testing
• Familiarity with Quality Management Systems (QMS)
• Ability to work collaboratively within a team
• Effective communication skills

Education:

• M.Sc. in Microbiology or Biotechnology
• Equal Opportunity Employer
• Role: Quality Assurance - Other
• Industry: Pharmaceutical & Life Sciences
• Department: Quality Assurance
• Employment Type: Full Time, Permanent
• Role Category: Quality Assurance - Other

Education:

• UG: Any Graduate
• PG: Any Postgraduate

Key Skills:

• EHS Quality Standards Microbiology Compliance Analytical Testing QMS Equipment Calibration Operations Monitoring PTS