Biotech QA Job at Syngene – Apply Online
Title: Quality Assurance Personnel- GLP
Date: 27 Jan 2025
Job Location: Bangalore
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 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 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 with Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), and ICH and NABL ISO 17025:2017 Testing requirements.
Role Accountabilities
- QA personnel
- Handling of 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 reports.
- Preparation and/or review of SOPs and other documents related to QAU.
- Review of SOPs, 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/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted to the company.
- Prepare the data for quality meetings.
- Compilation of quality analytics for monthly meetings.
Syngene Values
All employees will consistently demonstrate alignment with our core values:
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience: 3-4 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: Post graduation in pharmacology / Biotechnology
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