Executive

Job Title: QMS

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

Job Description:

• Responsible for handling Training binder, MS tools i.e., EQMS, EDMS and LMS to new joiners. Adhering to ALCOA+ guidelines and following the best practices to meet all Syngene’s policies safety standards with Zero data integrity breaches.

Primary Responsibilities:

• Coordinate with related team for tracking and closure of CAPA.
• Coordinate with team for assigning LMS for new joiners.
• Handling Incident and deviation tracking and closure.
• Adhere to safe practices and contribute to the development of procedures, practices, and systems that ensure safe operations and compliance with the company's integrity and quality standards.
• Handle Change controls and to ensure closure of action item mentioned in CCF in coordination with the CFT team
• Manage off boarding process by coordinating with RQA.
• To upload new procedures for equipment and instrument.
• Perform a biennial review

Secondary Responsibilities:

• Issuance of training binder for all new joiners and attending new joiner requirement onsite and providing required training.
• Training binder filing and tracking and archival when required.
• Actively participate in Internal audits, provide documents, and support closure of audit points.
• On time completion of all the training courses assigned.
• Other responsibilities as assigned by the reporting manager.

Syngene Values

All employees will consistently demonstrate alignment with our core values

 Excellence

 Integrity

 Professionalism

Specific requirements for this role

Experience

Demonstrated Capability

Education

Experience: 0-3 yrs

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.