Quality Assurance Professional – GLP
Division: Essential Functions
Location: Bengaluru, India
Employment Type: Full-time
Experience Level: Experienced
Date Posted: January 14, 2026
About Syngene
Syngene is an innovation-led Contract Research, Development, and Manufacturing Organization (CRDMO) delivering integrated scientific services from early discovery through commercial supply. With a strong global footprint, Syngene partners with leading pharmaceutical, biotechnology, and life sciences organizations to deliver high-quality, compliant, and data-driven research solutions.
At Syngene, safety is a fundamental value embedded in every aspect of our operations. We maintain the highest standards of Environment, Health, Safety, Quality, and Data Integrity, with shared accountability across all roles.
Role Overview
Syngene is seeking an experienced Quality Assurance Professional – GLP to join its Quality Assurance Unit (QAU). This role plays a critical part in ensuring compliance with OECD Good Laboratory Practice (GLP) principles and global regulatory standards, supporting the integrity and reliability of non-clinical safety and bioanalytical studies.
The position offers exposure to regulated laboratory environments, inspections, audits, and Quality Management Systems (QMS), with a focus on bioanalytical studies involving large molecules.
Core Responsibilities
GLP Compliance & Regulatory Oversight
Ensure compliance with OECD GLP principles, ICH, and WHO-GCLP requirements
Support and manage regulatory inspections and internal/external audits
Review and approve Quality Management System (QMS) elements, including change controls, deviations, and CAPAs
Quality Assurance Activities
Perform and schedule study-based, facility-based, and process-based inspections for bioanalytical studies, including PK and ADA studies for large molecules
Conduct audits of raw study data and final study reports to ensure data integrity and regulatory compliance
Review study plans, Methods of Analysis (MOAs), and related documentation
Documentation & Systems Compliance
Prepare, review, and maintain SOPs and Quality Assurance Unit documentation
Review computerized system validation documentation in compliance with OECD Principle 17 and 21 CFR Part 11
Ensure equipment qualification and system controls meet regulatory and internal quality standards
Safety, Quality & Organizational Expectations
Maintain strict adherence to Syngene’s Environment, Health, and Safety (EHS) policies
Promote a culture of safety, quality, integrity, and operational excellence
Complete all mandatory trainings related to data integrity, safety, and compliance on time
Monitor and review safety and quality metrics and support continuous improvement initiatives
Required Qualifications & Experience
Education:
Master’s degree in Pharmacology or Life Sciences from a recognized institution
Experience Required:
4–8 years of experience in a GLP-regulated Quality Assurance environment
Hands-on experience in GLP laboratories, preferably within a CRO or regulated bioanalytical setting
Demonstrated experience handling QMS processes, audits, inspections, and regulatory documentation
Key Skills & Competencies
Strong understanding of GLP, OECD, ICH, WHO-GCLP, and 21 CFR Part 11 regulations
Experience reviewing bioanalytical study data, reports, and validation documentation
Scientific mindset with strong analytical and problem-solving capabilities
Proficiency in handling multiple software tools and quality systems
Excellent written and verbal communication skills
Collaborative team player with high attention to detail
Syngene Core Values
All employees are expected to consistently demonstrate alignment with Syngene’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Employer
Syngene is an equal opportunity employer and is committed to building a diverse and inclusive workplace. Employment decisions are made without regard to age, race, gender, disability, religion, sexual orientation, marital status, or any other legally protected characteristic. Reasonable accommodations are provided to qualified individuals with disabilities in accordance with applicable laws.
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