Quality Assurance Personnel- GLP

JOB DESCRIPTION

Job Title: Quality Assurance Personnel- GLP

Job Location: Bangalore

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:

To Ensure compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), and ICH and NABL ISO 17025:2017 Testing requirements

Job Description

• Handling of QMS-Change controls, deviations, and CAPA
• Performing/scheduling study, facility, and process-based inspections for Toxicology and Mutagenicity studies.
• Perform audit of study raw data & study report.
• Preparation and /or review of SOPs and other documents related to QAU.
• Review of SOPs and study plans.
• Receipt and review of general documents/SOPs, Study Plans, and Study Reports.
• Maintain copies of approved Study Plans and general documents.
• Review of computerized system documents concerning OECD 17,21 CFR Part 11.
• Follow environmental, health, and safety (EHS) requirements in the workplace, ensuring individual and lab safety.
• Prepare the quality analytics for quality meetings.
• Supporting external and internal audits
• Support in Implementation of organizational objectives

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

Experience - 6-9 Years

Skills and Capabilities

• Strong commitment towards work and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking, listening, and writing skills, attention to detail, and proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be able to work in a team and flexible when working shifts.
• Should be a focused team member

Education

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.