Pharma QA Job Opening at Syngene – Apply Online
Title: Specialist Research Quality Assurance – Chemistry
Date: 25 Jun 2024
Job Location: Hyderabad
Pay Grade: 9-II
Year of Experience: 3 – 6 Years
Job Title: Specialist Research Quality Assurance – Chemistry
Job Location: Hyderabad
Job Grade: Senior Executive (9-II)
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 the development of procedures, practices, and systems that ensure safe operations and compliance with the 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 the safety of self, teams, and lab/plant by adhering to safety protocols and following EHS requirements at all times 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’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:
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 Trackwise.
- Review and approval of SOP, IOP, OCP, and EOP.
- Handling customer projects and ensuring that the documents are reviewed and approved.
- Review of audit trails 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
- Professionalism
Accountabilities 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 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: 2-4 years of relevant experience
- Demonstrated Capability: Team player, Result-oriented, and focused
- Education: Master’s degree in pharmacy/Science
- Experience: 2-4 years of relevant experience
- Skills and Capabilities: Team player, Result-oriented, and focused
- Education: Master’s degree in pharmacy/Science
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