Quality Assurance Job at Syngene | Pharmacology Graduates Apply Now
Syngene International Limited is hiring an experienced Quality Assurance Personnel – GLP for its laboratory operations in Bengaluru. This Quality Assurance Job within the Quality Assurance Unit (QAU) ensures that non-clinical safety studies comply with global OECD Principles of Good Laboratory Practice (GLP). The successful candidate in this Pharmacology Job will oversee bioanalytical inspections for large molecules (PK and ADA studies), manage QMS deviations, and ensure data integrity in alignment with 21 CFR Part 11 and ICH standards.
About The Company
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.
Requirements
- Overall adherence to safe practices and procedures of oneself and the teams is aligned.
- Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
- Driving a corporate culture that promotes an EHS mindset and operational discipline at the workplace at all times.
- Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environmental, 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 oneself.
- Compliance with 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.
Purpose of the Role
This Pharmacology Job is an exciting opportunity to play a role in the 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
- 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, study plans, and MOAs.
- Performing/scheduling study, facility, and process-based inspections for Bioanalytical studies (PK and ADA studies- Large Molecules).
- Perform an audit of the 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.
Education
Master’s degree in Pharmacology or any life sciences with a strong foundation and comprehensive expertise.
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 the qualification of equipment and computerized system documentation to ensure compliance with OECD Principles 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 a collaborative mindset.
- Good communication skills.
