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Specialist Research Quality Assurance
3 months ago
Job Title: Specialist Research Quality Assurance -Chemistry
Job Location: Hyderabad
Job Grade: Senior Executive (9-II)
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 timeCore Purpose of the Role:
Ensure laboratory compliance aligns with internal standards and procedures in Discovery Chemistry and other laboratories . Other responsibilities as assigned by the reporting manager.Role Accountabilities:
Review and approval of laboratory Change control, deviations, investigations, and CAPA in Track wise. Review and approval of SOP, IOP, OCP, and EOP. Handling customer projects and ensuring that the documents are reviewed and approved. Review of Audit trials of application software instruments and electronic lab notebook (eLN). Review and approval of Instrument qualification and scheduled calibration documents. Coordinating with laboratory personnel to handle customer queries. Issuance of workbooks and logbooks. Review of regulatory submission documents if any. Ensuring training compliance in line with training procedures and role-based curricula. Ensure lab compliance with respect to the laid down quality systems. Review and approve analytical documents comprising chromatographic data files, Lab Notebooks, and eLN. Review and approval of computerized system validation documents. Review and approval of Instrument qualification and scheduled calibration documents. Coordinating with laboratory personnel to handle customer queries.Leadership Capabilities: Not applicable
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence Integrity ProfessionalismAccountabilities as a Syngene Leader (only for Leadership Hires)
Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities. Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance. Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.Specific requirements for this role
Experience: Demonstrated Capability: Team player, Result-oriented and focused Education: Master’s degree in pharmacy / ScienceExperience: 2-4 years of relevant experience
Skills and Capabilities: Team player, Result-oriented and focused
Education: Master’s degree in pharmacy / Science
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.
