Section Head Microbiology

JOB DESCRIPTION

Job Title: Section Head Microbiology

Job Location: Bangalore

About Syngene : Syngene ( www.syngeneintl.com ) 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 ensures safe operations and compliance to company s 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 trainings related to data integrity, health, 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:

• Provide coaching to employees on compliance issues and establish measures to prevent noncompliance with cGMP and GDocP procedures.
• Guide employees on compliance with the Data Integrity policy, ensuring measures are in place to prevent non-compliance.
• Coach employees on adherence to SOPs and approved instructions, implementing measures to mitigate risks of noncompliance.
• Ensure the training and qualification of laboratory employees for their assigned activities.
• Conduct self-inspections as scheduled and maintain laboratory operations in an all-time audit-ready (ATAR) state for regulatory and client inspections.
• Monitor and implement ideas to reduce laboratory errors, increase productivity, and maintain a trend of continuous improvement.
• Ensure compliance with observations from internal, client, and regulatory audits.
• Identify gaps and improvement opportunities in existing procedures, infrastructure, and practices, ensuring alignment with current regulatory requirements and industry best practices.
• Ensure timely investigation and closure of all QMS events triggered during analytical activities.
• Oversee the implementation and monitoring of CAPAs applicable to the department.
• Prepare the annual budget and ensure laboratory operations remain within the specified limits.
• Ensure the qualification of microbiology equipment as per the required standards.
• Prepare and communicate MIS (Management Information System) reports to management and stakeholders.
• Ensure timely and appropriate responses to audit observations, whether internal, client, or regulatory.
• Prepare periodic trends and take necessary actions.
• Support in qualification of aseptic manufacturing facility.

Role Accountabilities:

• Timely completion of tasks and ensuring regulatory compliance in the laboratory.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1. Experience: 14- 17 years
2. Demonstrated Capability

• Good Knowledge of Biologics Manufacturing and testing compliance requirements.
• Good communication
• Co-operation with team leads.
• Good knowledge of aseptic practices

1. Education: MSc Microbiology

Skills and Capabilities

• Aggressive but assertive on task completion.
• Personal integrity and good attitude.

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 law. In addition, Syngene will provide reasonable accommodation for qualified individuals with disabilities.