Title: IPQA team member
JOB DESCRIPTION
Job Title: IPQA Team member
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: Team member – In process quality assurance
Role Accountabilities:
Handling shift activities of IPQA.
Proving line clearance for batch manufacturing activities.
Review of batch manufacturing records.
Cell bank management
Perform audit trail review of cGxP computerized systems
Leadership Capabilities: NA
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Accountabilities as a Syngene Leader (only for Leadership Hires)
- Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
- Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.
- Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.
Specific requirements for this role
- Experience
- Demonstrated Capability
- Education
Experience: 4-8years
Skills and Capabilities:
- Experience in DS manufacturing activities (upstream & downstream process) of biological products (Preferably mAbs).
- Should have knowledge on line clearance process of DS manufacturing activities.
- Should have understanding on audit trails verification of GxP computerized systems.
- Understanding on process equipment handling & operating systems.
- Understanding on WH activities like material receipt, dispensing and handling of rejected materials.
- Basic understanding on cGMP regulations
Education: Master’s in life sciences / B.Tech-Biotechnology
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.