Synergen Bio has announced openings for Research Associate-I (Clinical Quality Assurance). Candidates with B.Pharm or M.Pharm qualifications and 3+ years of experience in clinical QA, audits, GCP compliance, and regulatory documentation are encouraged to apply.
This is an excellent opportunity for professionals seeking to advance their career in Clinical Quality Assurance, GCP compliance, clinical audits, SOP management, and regulatory affairs within a leading bioanalytical and clinical research environment.
Job Overview
| Particulars | Details |
|---|---|
| Company Name | Synergen Bio |
| Position | Research Associate-I |
| Department | Clinical Quality Assurance |
| Qualification | B.Pharm / M.Pharm |
| Experience | 3+ Years |
| Vacancies | 02 |
| Preference | Immediate Joiners |
| Application Mode | |
| Email ID | careers@synergenbio.com |
Key Responsibilities
The selected candidates will be responsible for:
Clinical Audit & Compliance
- Conduct in-process audits for various clinical phases of bio studies as per approved protocols.
- Perform retrospective audits of raw data, study reports, and e-CTD documentation.
- Ensure compliance with SOPs, GCP guidelines, and applicable regulatory requirements.
- Verify corrective and preventive actions (CAPA) arising from QA observations.
Quality Assurance Activities
- Update and report project audit status to QA leadership.
- Review and prepare SOPs while ensuring system compliance.
- Conduct system audits for internal departments, contracted facilities, and vendors.
- Prepare authentication statements for study reports.
Documentation & Change Control
- Manage generation, distribution, reconciliation, and retrieval of project-related documents.
- Review change control documentation and implementation records.
- Maintain archival, storage, and retrieval of study documentation.
Training & Regulatory Support
- Deliver training programs on GCP and regulatory requirements.
- Coordinate training schedules and maintain training records.
- Support continuous quality improvement initiatives.
Equipment & Validation Review
- Verify calibration records and validation documentation including DQ, IQ, OQ, and PQ.
- Conduct trend analysis of deviations and quality metrics.
Required Qualifications
Educational Qualification
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
Experience
- Minimum 3 years of relevant Clinical Quality Assurance experience.
Desired Skills
- Good Clinical Practice (GCP)
- Clinical Audit Management
- Regulatory Compliance
- SOP Writing & Review
- CAPA Management
- Vendor Audit & System Audit
- Clinical Documentation Review
- Change Control Management
- Validation Documentation Review
- Training Coordination
Why Join Synergen Bio?
- Opportunity to work in a highly regulated clinical research environment.
- Exposure to clinical quality systems and regulatory compliance.
- Career growth in Clinical QA and GCP compliance.
- Hands-on experience with audits, inspections, and validation processes.
- Collaborative and learning-focused work culture.
- Immediate joining opportunities for qualified professionals.
How to Apply
Interested and eligible candidates can share their updated CV directly to:
