Title:  Head Microbiology

JOB DESCRIPTION

Job Title: Head Of the Department (HOD)

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

1. Overall adherence to safe practices and procedures of oneself and the teams aligned
2. Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
3. Driving a corporate culture that promotes environment, health, safety and sustainability (EHSS) mindset and operational discipline at the workplace at all times.
4. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following  environment, health, safety and sustainability (EHSS) requirements at all times in the workplace.
5. 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
6. Compliance to Syngene’ s quality standards at all times
7. Hold self and their teams accountable for the achievement of safety goals
8. Govern and Review safety metrics from time to time

Core Purpose of the Role:

• Provide coaching to the related employee on the compliance issues and establish measures to prevent noncompliance from cGMP, GDP, and GLP procedures. Serve as subject matter expert for clients, regulators and Syngene staff working on projects or during designing proposal responses.
• Provide coaching to the related employee on the compliance issues and establish measures to prevent noncompliance from Data Integrity policy
• Provide coaching to the related employee on the compliance issues and establish measures to prevent noncompliance from SOP and approved instructions.
• Ensure training and qualification of laboratory employees for their assigned activities
• Ensure optimum utilization of resources in compliance with SQDEC parameters.
• Ensure self-inspection is performed as scheduled and laboratory operations are maintained in all-time audit ready (ATAR) manner for regulatory and client inspections.
• Monitor, implemented ideas and measures to reduce laboratory errors and increase productivity and maintain the trend.
• Ensure appropriate and timely response provided for the audit observations.
• Ensure compliance with the observations of an internal, client, or regulatory audit.
• Identify the gap and improvement opportunities for the existing procedure, infrastructure, and practices concerning current regulatory requirements and industry best practices.
• Ensure all the QMS events triggered during analytical activities are investigated appropriately and closed in time.
• Monitor the implementation of CAPA applicable to the department.
• Prepare annual budget and ensure laboratory operation within the specified budget.
• Prepare and communicate MIS reports with management and stakeholders.
• Ensure prompt and effective client and CFT communication.

Role Accountabilities

Driving a corporate culture that promotes those values of the organisation. To lead the QC microbiology team.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

• Well versed with MS Office (Word, PowerPoint, Excel) and MS Projects
• Good command in English both oral and written and customer service skills
• Having worked on injectables / sterile
• Good time-management skills
• Great interpersonal and communication skills
• Possess the knowledge and exposure to microbiology, QC.

Experience

20+ years of experience in Biotechnology, Pharma (R&D, API's and Formulations), Pharmaceutical, CRO, CDMO

Skills and Capabilities

• Ability to multi-task and independently handle cross-functional projects with multiple stakeholders
• Experience in leading projects and managing client relationships
• Exceptional interpersonal skills, ability to work with cross functional departments, manage client relationships.
• Effective communication
• Commitment to Safety
•  Knowledge and application of subject

Education

M.Sc / M.Pharma

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 accommodations for qualified individuals with disabilities.