Quality Assurance Personnel - GLP
Date: 17 Feb 2025
Job Location: Bangalore
Pay Grade: Not Specified
Years of Experience: 6-9 Years
About the Company
Syngene (www.syngeneintl.com) is a leading contract research, development, and manufacturing organization focused on delivering integrated scientific solutions from early-stage discovery to commercial production. At Syngene, safety is a top priority, embedded into both personal and professional commitments. The organization upholds safety as a fundamental aspect of performance, ensuring compliance with all safety procedures, guidelines, and standard operating protocols (SOPs).
Safety Expectations for All Roles
- Adhering to safety practices and procedures in all operations.
- Contributing to the development of systems, procedures, and practices that promote safety, quality, and compliance.
- Fostering a workplace culture that prioritizes environmental, health, and safety (EHS) standards.
- Ensuring individual and team adherence to EHS protocols at all times.
- Completing mandatory training related to data integrity, health, and safety measures within the required timeframe.
- Upholding Syngene’s quality standards and holding team members accountable for achieving safety objectives.
- Regularly monitoring and reviewing safety metrics to maintain compliance.
Role Purpose
The primary objective of this role is to ensure compliance with the Organization for Economic Co-Operation and Development (OECD) Good Laboratory Practices (GLP) principles, as well as ICH and NABL ISO 17025:2017 testing requirements.
Key Responsibilities
- Managing Quality Management System (QMS) components, including change controls, deviations, and corrective and preventive actions (CAPA).
- Conducting and scheduling study, facility, and process-based inspections for toxicology and mutagenicity studies.
- Performing audits of study raw data and reports.
- Preparing and reviewing SOPs and other Quality Assurance Unit (QAU) documents.
- Reviewing study plans, general documents, SOPs, and study reports.
- Maintaining copies of approved study plans and general documents.
- Assessing computerized system documentation in accordance with OECD 17 and 21 CFR Part 11 compliance standards.
- Following workplace environmental, health, and safety (EHS) regulations to ensure a safe working environment.
- Compiling quality analytics for internal quality meetings.
- Assisting with internal and external audit processes.
- Supporting the implementation of organizational objectives.
Key Skills and Competencies
- Strong dedication to work with a high level of motivation and enthusiasm.
- Excellent communication skills, including speaking, listening, and writing.
- Strong attention to detail with a proactive approach.
- Ability to work effectively in dynamic and fast-paced environments.
- Capacity to meet deadlines and manage workloads efficiently.
- Problem-solving skills with an innovative mindset.
- Team-oriented with flexibility for shift work.
Educational Requirements
- M.Sc. in a relevant field.
Company Values
All employees are expected to uphold Syngene’s core values:
- Excellence
- Integrity
- Professionalism
Equal Opportunity Policy
Syngene is committed to providing equal employment opportunities to all individuals, regardless of age, race, color, nationality, disability, religion, gender identity, sexual orientation, marital status, or any other legally protected characteristics. The company also ensures reasonable accommodations for qualified individuals with disabilities.
How to Apply
Interested candidates can apply via the official career portal: Apply Here