Title: Stability Operations Associate
JOB DESCRIPTION
Job Title: Stability Operations Associate
Job Location: Syngene International Limited, Bengaluru
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:
This is an exciting opportunity to play a role in the QC LATE PHASE STABILITY (Stability Operations) of Syngene. The role will provide end-to-end exposure to the stability operations. It provides an opportunity to work with several cross-functional teams and deliver for the customer.
Role Accountabilities
Accountable for the routine activities of stability operations like stability sample inception, pullout, and preparation of stability study protocols in LIMS labware. Reviewing stability chamber data. Preparation of stability operations procedures. Initiation of change controls and active participation in client and regulatory audits. Ensuring Stability operations are always audit-ready. Execution of equipment qualification and software validation. Supporting the chamber's preventive maintenance and calibration.
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: 03 to 06 years
Work experience in handling stability chambers and stability sample management.
Hands on experience in LIMS labware and Trackwise.
Must have experience in facing regulatory audits.
Skills and Capabilities
Good understanding of cGMP and Data Integrity aspects.
Work as a team and have a collaborative mindset
Good communication skills
Good English writing skills.
Education
B. Pharm/M.Sc.
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.