About this role

Designation: Manager - QMS
Department: Early Phase GMP (Analytical Development)
Job Location: Bangalore

Job Description

At Syngene, Safety is at the heart of everything we do, personally and professionally. Syngene places safety at par with business performance, with shared responsibility and accountability for following safety guidelines, procedures, and SOPs in letter and spirit.

Mandatory Expectations for All Roles as per Syngene Safety Guidelines

- Overall adherence to safe practices and procedures for self and aligned teams.

- Contribute to the development of procedures, practices, and systems that ensure safe operations and compliance with company integrity and quality standards.

- Drive a corporate culture that promotes an Environment, Health and Safety (EHS) mindset and operational discipline at all times.

- Ensure safety of self, team members, and laboratory/plant by adhering to safety protocols and EHS requirements.

- Ensure completion of all mandatory trainings related to data integrity, health, and safety by self and team members within stipulated timelines.

- Ensure compliance with Syngene quality standards at all times.

- Hold self and team accountable for achieving safety goals.

- Govern and review safety metrics periodically.

Job Responsibilities

- Investigate laboratory incidents, deviations, OOS (Out of Specification), OOT (Out of Trend), and related quality events.

- Ensure all investigations are completed accurately and within timelines.

- Identify root causes of analytical failures and implement effective CAPA.

- Support audit compliance activities and ensure timely closure of audit observations.

- Respond to regulatory inspection observations and surveillance findings.

- Provide training related to investigation outcomes and quality processes.

- Ensure team alignment with Early Phase GMP objectives and goals.

- Manage client and regulatory audits and provide satisfactory responses within defined timelines.

- Ensure all team members are appropriately trained and qualified.

- Drive continuous improvement initiatives within the function.

- Ensure implementation and compliance with quality systems.

- Ensure adherence to current quality processes and procedures.

- Optimize work allocation and prioritize activities to meet departmental commitments.

- Ensure compliance with Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and Data Integrity requirements.

- Review protocols, reports, specifications, preventive maintenance records, observation data sheets, temperature mapping documents, and related records.

- Participate in and close investigations related to OOS, OOT, laboratory incidents, deviations, CAPA, and non-conformances.

- Raise QMS and Change Control records in TrackWise and maintain documents in EDMS as required.

- Ensure compliance with laboratory safety standards, Syngene policies, and EHSS requirements.

- Prepare, review, and update procedural documents including SOPs, IOPs, and Guidance Procedures as required.

- Interact with clients and project teams for smooth execution of project activities.

- Monitor analytical activities and associated documentation for compliance with SOPs, protocols, and specifications.

- Coordinate with cross-functional teams within Early Phase GMP for timely completion of investigation-related activities.

- Review instrument usage logs and verify equipment labeling compliance as per SOP requirements.

- Perform any additional responsibilities assigned by the Department Head.

Education & Experience

Qualification: M.Sc. or M.Pharm
Experience: 10 to 15 years

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunity (EEO) to all applicants and employees regardless of age, colour, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. Reasonable accommodations will be provided for qualified individuals with disabilities.