Manager Development Quality Assurance (BRDS)

JOB DESCRIPTION

Job Title : Manager Development Quality Assurance (BRDS)

Department : Discovery and Development QA

Job Location: Bengaluru, India

About Syngene:  Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas

We are seeking an experienced and dynamic Quality Assurance lead to manage research and development quality assurance division at Bicara Research and Development at Syngene (BRDS). This role will involve implementing Syngene Quality Assurance principles for Biologics development and ensuring compliance to quality systems throughout the life cycle of R&D projects.

 Mandatory expectation  

• Responsible and accountable towards safety and compliance in all the work activities in the own responsibility area(s).
• Monitor and confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self and direct reports.
• Monitor and confirm that self and direct reports adhere to the highest standards of quality, integrity and compliance for every work activity.
• Complete the assigned training in a timely manner and comply with the training procedure and training calendar and monitor and confirm the same for the direct reports.
• Attend all assigned mandatory training related to data integrity, health and safety measures, and monitor and confirm the same for the direct reports.
• Participate and support the training on procedures, protocols and On-the-Job activities.
• Comply with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Report nonconformities and deviations to the respective supervisor(s) and/or line manager(s).
• Participate and support on-time initiation and closure of deviations, investigations, CAPA and change controls.

Educational Qualification:  

• Masters or Doctorate degree in Pharmaceuticals, Biotechnology, Engineering or any stream of Science.

 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 for Bicara 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

• Lead Quality Management System activities pertaining to Bicara Research and Development at Syngene.
• Liaise with Bicara Global Quality to align on quality principles and process flow for discovery and development projects at BRDS.
• Execute quality risk assessment across different development stages of Biologics Discovery and Development and implement phase appropriate QMS principles. 
• Ensure that OOS, Deviations, Customer Complaints are investigated, reviewed and CAPA implemented in accordance with QMS requirements. Ensure change controls are assessed.
• Coordinating with Cross functional team other GxP functions for the implementation of Quality Management System (QMS).
• Training of employees on QMS procedures.
• Prepare / Review of documentation such as Quality Manual, Site Master Files, SOPs and Quality Agreements.  
• Planning and follow-up of QMS activities for closure within the target timeline for Biologics Operation Units.
• Preparation of QMS Metrics within BRDS.
• Preparation and review of risk assessment for Quality activities.
• Preparation and review of trends as per schedule for all QMS elements as applicable.
• Liaise with and support the Internal Audit and Continuous Improvement team for the timely closure of the CAPA.
• Facilitate continuous improvement via QMS to improve the health of the Quality Systems.
• Participate and coordinate the client and regulatory audits for Biologics Discovery and Development Labs.
• Development of team skills within Biologic-QA team, motivating, coaching and mentoring direct reports to higher levels of management capabilities.
• Review of SOPs within QA, periodic review of the SOPs implemented across the functions.
• Ensure quality compliance against regulatory requirements and revise SOPs as necessary to comply with these regulations.
• Accountable for reviewing and approving protocols, SOPs, IOPs and documents related development, method qualification, Specifications, Tech-Transfer, etc.
• Responsible for approval and timely availability of Technology Transfer from Development services to Manufacturing services; Analytical Method and Process Development Transfer documents.
• Develop role-based training modules for BRDS and ensure training of staff on quality procedures, processes, policies and issue training binders.
• Implement phase appropriate quality procedures and DI related training across operating units.
• Review and approval of Quality Assurance procedures in EDMS and TrackWise.
• Implementation of role-based curricula in Discovery and Development Services and ensure compliance.
• Approve annual training planner, instrument audit trail and eLN audit trail schedules.
• Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity and quality standards.
• Coordination with cross-functional teams to complete the assigned work on time such as data review, report approval, etc.
• Execute root cause investigation by performing why-why analysis and propose mitigation strategies and implement CAPAs.
• Responsible for facing audits by clients and regulatory bodies.
• Lead regular meetings with team members to communicate operational information and objectives.
• Evaluate team performance periodically and identify areas in need of improvement to implement development strategies.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Experience

• 10+ years of experience in driving quality assurance in pharmaceutical/biopharmaceutical industry

Skills and Capabilities

• Proven track record in implementing QMS in biologics development and QC labs.
• Strong understanding of biologics development process flow including early-stage process development, scale-up and technology transfer.
• Good knowledge of international quality guidelines applied for biologics drug development including ICHQ, USP, etc.
• Knowledge of electronic notebooks and should be well versed in TrackWise QMS Software for raising Deviation, Change Control and CAPA. 
• Excellent interpersonal communications with track record of working in dynamic environment