Development Quality Professional

JOB DESCRIPTION Job Title Specialist Development 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 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 to drive Phase gate for Product Development across Formulation Development functions Review and approval of Formulation development reports QbD reports risk assessment reports Hold time study reports and other documents generated for formulation development projects Review and Assess risk associated with process and Mitigation Plan Review and provide inputs on analytical method to have robust methods Review and approval of Formulation Technology Transfer from Development services to Manufacturing Review and approval of Method transfer documents and Specifications for all early and late phase programs Review and approval of formulation development reports and QbD reports during development Review and approval of transfer protocols reports Coordination with cross-functional teams to complete the assigned work on time and data review Responsible for reviewing scientific experiments as per project requirements in a process development laboratory catering to formulation development Providing the exact root cause for the issues and performing why-why analysis to understand the challenges Review of Quality Assurance procedures in EDMS Contributing to development procedures practices and systems that ensure safe operations and compliance with the company s integrity quality standards 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 Support for facing Customer audits and their related compliance Support for handling customer queries related to quality compliance with Development OUs Overall adherence to safe practices and procedures of oneself and the teams aligned Driving a corporate culture that promotes environment health and safety EHS mindset and operational discipline at the workplace Ensuring the safety of self teams and lab plant by adhering to safety protocols and following environment health and safety EHS requirements always in the workplace Ensure all assigned mandatory training related to data integrity health and safety measures are completed on time by all members of the team including self Compliance with Syngene quality standards and Data integrity policies always Hold self-accountable for the achievement of safety goals The Successful Applicant Master s degree in Pharmacy Master s in chemistry life sciences both preferable Minimum 10 -15 years of experience in pharma industry in process development and chemical development with at least 5- 10 years of process development environment manufacturing Proven track record of successfully managing and leading respective time Sound knowledge of formulation development techniques Sound knowledge on Guidelines such as ICH USP etc Strong understanding of regulatory requirements Excellent communication Interpersonal and problem-solving skills Ability to work effectively with cross functional teams and OU s Technology Transfer development to manufacturing Knowledge to set acceptance criteria for process validation and transfers Handle technology transfer and data review as apert of transfer Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience 10 years of relevant experience Skills and Capabilities Exposure to Drug Development and Commercial Technology Knowhow Compliance management Process Excellence Execution focus Accountability Collaboration Education Master s degree in Pharmacy master s in chemistry life sciences or Ph D in both preferable