Head QA Biologics

JOB DESCRIPTION

Job Title: Head QA Biologics

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 ensures safe operations and compliance to 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 trainings 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:

This is an exciting opportunity to play a role in Quality Assurance team Biologics Business Unit of Syngene. The role will provide exposure to overseeing Quality Assurance operations for the Mammalian and Microbial manufacturing plants. The incumber will also evaluate and implement sustainable operational excellence initiatives within Quality Assurance department.

Role Accountabilities

The incumbent shall oversee all Quality Assurance operations like Analytical Quality Assurance (Analytical Bioassay and Microbiology) Engineering Quality assurance Manufacturing Quality assurance (IPQA) Quality Management Systems Vendor Quality Management Audits and Compliance sections. The incumbent shall oversee quality operations for Biologics Manufacturing Plant 1 (Mammalian) and Biologics Manufacturing Plant (Microbial) facilities.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1. Experience:

• Acting as a Thought Leader with experience in QA/QC Biologics with at least few years of mid-to senior-level leadership experience within Quality department.
• Handled QC or QA operations within Biologics quality department
• Hands on experience in executing Analytical and Bioanalytical method validations method transfers testing and release stability operations.
• Knowledge on execution and validation of Microbiological methods
• Experience on direct handling of regulatory inspections and client audits.
• Experience on operational excellence initiatives

1. Demonstrated Capability:

• Handling diverse functions within Quality department with a deep understanding on facility qualification method validations testing and release stability testing. Along with these technical skills the incumbent must be experienced in deploying Operational Excellence measures and people management.
• Rich knowledge on regulatory guidelines Quality risk management cross contamination strategy
• Excellent verbal and business communication
• Client focus
• Cross functional collaboration
• Lean Six Sigma Black belt or Green Belt (preferred)

1. Education: Masters (Chemistry/Biochemistry/Microbiology/Biotechnology) or Ph. D

Core responsibilities:

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 accommodations for qualified individuals with disabilities.