Title: Lead Development Quality Assurance
JOB DESCRIPTION
Job Title: Lead Development Quality Assurance Lead Development Quality Assurance
Job Location: Bengaluru, India
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
Profile Description:
This role will be responsible for crafting the allocation methodologies and process flows for Development services. This individual will collaborate actively with Operation units of development services to improve alignment and achievement of customer satisfaction and value realization
Core Purpose of the Role :
Responsible for Quality Systems of Development Services and relevant QA activities.
Role Accountabilities
- Responsible for implementation of Phase gate for Product Development across Development Services; Chemical Development, Biopharmaceuticals Development and Formulation Development.
2. Ensure and Assess risk associated with Analytical Methods and Mitigation Plan.
- Review and provide inputs on analytical method to have robust methods.
- Responsible for approval and timely availability Technology Transfer from Development services to Manufacturing services; Analytical Method and Process Development Transfer.
- Responsible for approval of Method transfer documents and Specifications for all early and late phase programs.
- Responsible for approval of Product development reports and QbD reports during Product development.
- Responsible for approval of Method Qualification and Method transfer protocols & reports.
- Preparation of Quality management review decks for OU Quality Review Meetings, MERM and Quality Governance Forum (QGF) for Discovery services.
- Review and Approval of Quality Manual.
- Ensuring all identified risks & its mitigation actions completion in line 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 operating units.
- Approval of Quality notification (as QA approver) in Trackwise ®.
- Review and approval of Quality Assurance procedures in EDMS.
- Implementation of Role-based curricula in Development Services and its verification.
- Approval of self-inspection, annual training planner, instrument audit trail & eLN audit trail schedules and its assurance.
- Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
- Coordination with cross-functional teams to complete the assigned work on time and data review.
- Providing the exact root cause for the issues and performing why-why analysis to understand the challenges
- Review and implementation of cross-deployment of CAPAs across Development OUs.
- Responsible for facing Customer audits and their related compliance.
- Responsible for handling customer queries related to quality & compliance with Development OUs.
- 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 Development Services and its verification.
- Chair SQDEC meeting.
- Other responsibilities as assigned by the reporting manager
The Successful Applicant
- Master’s degree in Pharmacy, Master’s in Biotechnology or Ph.D in both preferable
- Minimum 15 -20 years of experience in pharma industry in Manufacturing in Large molecules and Biopharmaceticals, with at least 5 10 years of leadership experience in similar production and testing environment.
- Proven track record of successfully managing and leading respective time.
- Sound knowledge of analytical techniques like the characterization of large molecules, CE, RCE, GEL electrophoresis, HPLC, SEC-MALS, Bioassay, and plate-based techniques.
- Sound knowledge on Guidelines such as ICH, USP
- Strong understanding of regulatory requirements
- Excellent communication, Interpersonal and problem-solving skills
- Leadership skills to motivate and develop a team
- Ability to work effectively with cross functional teams and OU’s.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Experience
- 5-10 years of relevant experience
Skills and Capabilities
- Exposure to Drug Development and Commercial
- Technology Knowhow
- Compliance management
- Process Excellence
- Execution focus’
- People developer
- Accountability
- Collaboration .
Education
Master’s degree in Pharmacy, Master’s in Biotechnology or Ph.D in both preferable