Title:  Quality Assurance Personal-GLP

JOB DESCRIPTION

Job Title: GLP-Quality Assurance Personal

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 GLP Quality Assurance Unit at Syngene. The role offers valuable exposure to aligning laboratory practices with GLP guidelines, which are crucial for ensuring the integrity and reliability of non-clinical safety and clinical studies. Additionally, it provides a chance to work in a regulatory environment, ensuring that Syngene adheres to national and international standards set by organizations such as OECD, ICH, and ISO.

Role Accountabilities

To Ensure compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), and ICH, WHO-GCLP. Handling of inspections and audits. Handling of QMS-Change controls, deviations, and CAPA Review of SOPs and study plans and MOAs. Performing/scheduling study, facility, and process-based inspections for Bioanalytical studies (PK and ADA studies- Large Molecules). Perform audit of study raw data & study report. Preparation and /or review of SOPs and other documents related to QAU. Review of general documents/SOPs, Study Plans, and Study Reports. Review of computerized system documents concerning OECD 17,21 CFR Part 11.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience

• Familiarity with the principles of Good Laboratory Practices (GLP) as outlined by the Organization for Economic Co-Operation and Development (OECD), along with knowledge of ICH and WHO-GCLP guidelines in GLP laboratories.
• Handling Quality Management System (QMS) activities, including change controls, deviations, and CAPA (Corrective and Preventive Actions).
• Reviewing Standard Operating Procedures (SOPs), study plans, and Methods of Analysis (MOAs).
• Conducting inspections related to studies, facilities, and processes, with a focus on Bioanalytical studies (PK and ADA studies involving large molecules).
• Auditing raw study data and study reports to ensure accuracy and compliance.
• Preparing and/or reviewing SOPs and other Quality Assurance Unit (QAU) documentation.
• Reviewing qualification of equipment and computerized system documentation to ensure compliance with OECD Principle 17 and 21 CFR Part 11 guidelines.

Skills and Capabilities

Expertise in handling multiple software applications and tools

Capable of thinking scientifically to address complex problems and develop solutions

Work as a team and have collaborative mindset

Good communication skills

Education

Master's degree in Pharmacology or any life sciences with a strong foundation and comprehensive expertise

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.