Stability Operations Associate

1 month ago

Bengaluru, India Syngene Full time

JOB DESCRIPTION

Job Title: Stability Operations Associate

Job Location: Syngene International Limited, Bengaluru

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.

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