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Lead Research Quality Assurance - Bengaluru, India - Syngene International Limited
Description
Job Title :
Lead
Research Quality Assurance
Department :
Discovery and Development QA
Job Location:
Bengaluru, India
About Syngene :
Syngene ( ) 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 spiritMandatory 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 selfCompliance 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 :
Responsible for Quality Systems of Development Functions and relevant QA activities.
Role Accountabilities
Preparation of Quality management review decks for OU Quality Review Meetings, MERM and Quality Governance Forum (QGF) for Discovery services.
Review and Approval Discovery Services Quality Manual.Ensuring all identified risks & its mitigation actions completion in line with Discovery services Risk register.
Ensuring training of team members on procedures, quality processes and policies.
Review and approval of team members training binders.
Imparting Phase appropriate quality procedures and DI related training across Discovery operating units.
Ensure training of RQA personnel and Discovery services Operations team on Corporate initiatives like SOP Vs Practices, ATAR, DI workshops etc.
Approval of Quality notification (as QA approver) in Trackwise .Review and approval of Discovery Quality Assurance procedures in EDMS.
Implementation of Role-based curricula in Discovery Services and its verification.
Approval of self-inspection, annual training planner, instrument audit trail & eLN audit trail schedules in RQA and its assurance.
Review and approval of protocols and reports in Discovery OUs (as applicable).
Review and implementation of cross-deployment of CAPAs across Discovery OUs.
Responsible for facing Customer audits and their related compliance.
Responsible for handling customer queries related to quality & compliance with Discovery OUs.
Responsible for ensuring GPTW initiatives implementation in RQA and its action items tracking.
Leading regular meetings with team members to convey important operational information and new targets.
Responsible for evaluating team performance continuously to identify areas in need of improvement and implement strategies to keep them on track.
Implementation of Role-based curricula in Discovery Services and its verification at SSSLChair SQDEC meeting.
Other responsibilities as assigned by the reporting manager.
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience
15 + years of relevant experience
Skills and Capabilities
Team player, Result oriented and focus.
Education
Master's degree in pharmacy / Mater in Science / MBA/ Ph.
D
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.
