Head Microbiology

JOB DESCRIPTION

Job Title: Head of Microbiology

Level: Expert

Job Location: Syngene International Limited Bengaluru

About Syngene: Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures practices and systems that ensure safe operations and compliance with the companys integrity & quality standards
• Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self teams and lab/plant by adhering to safety protocols and following environment health and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory training related to data integrityhealth and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

To support the Small molecule and Large molecule business for Microbiology testing ensuring compliance with GMP Quality standards regulatory expectations and Syngene policies. The role requires driving safety operational discipline documentation excellence and continuous improvement within the QC Microbiology teams.

Role Accountabilities

1. Safety & Compliance Supporter ship

• Ensure adherence to all safety practices and procedures.
• Drive an EHS-focused culture that promotes safe behaviour operational discipline and integrity.
• Ensure completion of all mandatory training related to data integrity safety and compliance for self and team members.
• Monitor and review safety performance metrics and hold teams accountable for achieving safety goals.

1. Quality Oversight and Governance

• Provide strategic oversight for Small molecules and Large molecule operations.
• Ensure compliance with global GMP standards and regulatory expectations.
• Enable informed decision-making on quality batch disposition and compliance risks.
• Oversee timely execution of QC deliverables including audits trend reviews complaints and document assessments.
• Align microbiology operations with organizational goals regulatory expectations and business priorities.
• Drive operational excellence through digitalization (LIMS/ELN) efficiency improvements and standardization.
• Promote Syngene core values: Excellence Integrity Professionalism.

1. Documentation & Regulatory Compliance

• Ensure compliance with all documents related to QC Microbiology operations including:

• Annexures ODS calibration sheets log sheets
• Specifications
• SOPs/IOPs/EOPs
• Equipment qualification documents (IQ/OQ/PQ)
• CSV documents protocols and reports

• Ensure document adequacy with respect to ALCOA principles.
• Support issuance and control of quality documents.

1. Quality System Management

• Participate in investigations and review:

• Deviations
• Laboratory incidents
• Out-of-calibration events
• Out-of-specification (OOS) results
• Out-of-trend (OOT) observations
• Corrective and Preventive Actions (CAPA)

• Review the appropriate CAPA is taken and verifying their effectiveness.

1. Client & Cross-functional Support

• Handle customer projects by reviewing QC Microbiology documentation.
• Communicate quality-related matters to clients effectively and professionally.
• Collaborate with QA and cross-functional teams to support QMS-related activities.

1. Training & Team Development

• Ensure all new and existing personnel are trained adequately for their assigned responsibilities.
• Train QC team members on quality system regulations policies and best practices.
• Promote a culture of continuous improvement and quality excellence.

1. Internal Audits & GMP Compliance

• Conduct GMP rounds in QC Microbiology laboratories.
• Participate in self-inspections and ensure corrective actions are implemented effectively.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

Demonstrated Capability on Microbiological Testing Oversight Method & System Knowledge Quality Control Responsibilities system implementation and governance Deviation & CAPA Management Regulatory & Compliance Audit & Inspection Readiness Cross-Functional Collaboration

The Head of Microbiology is responsible for ensuring overall microbiological controls meet global GMP and regulatory expectations through scientific review compliance oversight and leadership enabling safe sterile and reliable biologics manufacturing.

Skills and Capabilities

• Thorough understanding of GMP microbiology testing (Sterility BET Bioburden Microbial Limits)
• Expertise in environmental monitoring (viable & nonviable) and cleanroom classification
• Strong knowledge of water systems microbiology (PW WFI)
• Oversight of culture media preparation qualification and GPT
• Experience with method validation / verification for microbiological methods
• Scientific assessment of microbiological deviations OOS/OOT and atypical results
• Lead root cause investigations using riskbased tools (5Why Fishbone FMEA)
• Development approval and effectiveness monitoring of CAPAs Support batch disposition decisions related to microbiology events
• Strong data integrity (ALCOA) assessment capability
• Working knowledge of LIMS and electronic data review
• Capable of thinking scientifically to address complex problems and develop solutions.
• Work as a team and have collaborative mindset
• Good communication skills

Education

Education : . / / PhD in Microbiology Biotechnology Life Sciences or related discipline

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodation for qualified individuals with disabilities.