Are you looking for an exciting opportunity in clinical quality assurance? Syngene International invites applications for the position of Clinical QA Auditor at their Bangalore location. Join a pioneering organization at the forefront of scientific innovation, offering a rewarding career path in the pharmaceutical and biotechnology industries.
About Syngene
Syngene International (www.syngeneintl.com) is an innovation-driven Contract Research, Development, and Manufacturing Organization (CRDMO) delivering end-to-end scientific services. With a focus on safety and quality, Syngene partners with global organizations to bring innovative solutions from discovery to commercial supply.
At Syngene, safety and compliance are integral to our operations, aligning with our commitment to operational discipline, health, and sustainability.
Responsibilities in the Role
As a Clinical QA Auditor, your primary duties include ensuring adherence to regulatory guidelines, company SOPs, and quality standards in clinical studies. Key responsibilities are:
- In-Process Audits: Perform study-specific in-process audits to ensure compliance with study protocols, in-house SOPs, and regulatory guidelines.
- Retrospective Audits: Review informed consent documents, trial master files, case report forms, and draft clinical study reports for compliance.
- Database Audits: Conduct audits within EDC applications for applicable studies.
- Audit Reporting: Prepare and issue audit reports, monitor corrective actions, and ensure timely closure of observations.
- Change Control: Initiate and review change controls and deviations, ensuring their timely closure.
- Document Reviews: Assist in reviewing and finalizing critical documents, including protocols, ICDs, and CRFs.
- System and Vendor Audits: Participate in system and vendor audits as a lead or co-auditor.
- Inspection Readiness: Contribute to internal and external audits, inspections, and CAPA preparation.
You’ll also assist in quality metrics reporting, escalate significant non-compliances, and contribute to archiving QA records.
Qualifications and Experience
To excel in this role, candidates must meet the following criteria:
- Education: M.Sc. or M.Pharm degree in a relevant field.
- Experience: 6-9 years of professional experience in clinical quality assurance.
- Skills:
- Proficient auditing skills.
- Thorough understanding of regulations and guidelines.
- Attention to detail and adherence to the ALCOA+ principles.
Core Values at Syngene
All employees are expected to embody Syngene’s core values:
- Excellence
- Integrity
- Professionalism
These principles ensure a collaborative, inclusive, and forward-thinking workplace.
