Looking for Clinical Research, Clinical Quality Assurance, or Bioequivalence Study jobs in Pune? Synergen Bio, a leading bioequivalence and clinical research organization, is hiring experienced professionals for multiple positions including Clinical Research Associate (CRA), Clinical Quality Auditor, and Research Associate-I (Clinical Quality Assurance) at its Pune facility.
Candidates with B.Pharm or M.Pharm qualifications and relevant industry experience can apply immediately. The company is conducting face-to-face interviews and prefers immediate joiners.
About Synergen Bio
Synergen Bio is a reputed Contract Research Organization (CRO) specializing in bioavailability (BA) and bioequivalence (BE) studies, clinical research services, quality assurance, and regulatory compliance activities. The organization follows stringent regulatory standards and Good Clinical Practice (GCP) guidelines to support pharmaceutical and biotechnology companies.
Job Openings at Synergen Bio
1. Clinical Quality Auditor
Department: Quality Assurance
Location: Shivajinagar, Wakadewadi, Pune
Qualification: B.Pharm / M.Pharm
Experience: 5+ Years
Vacancies: 2
Key Responsibilities
- Conduct in-process and retrospective audits of clinical raw data, PK data, and statistical data.
- Review protocols, informed consent forms, clinical study reports, Module 2.7.1, DBE tables, and eCTD compilations.
- Ensure implementation of Quality Management Systems (QMS).
- Manage deviations, change controls, CAPA activities, and trend analysis.
- Conduct system audits and vendor audits.
- Respond to sponsor and regulatory audit observations.
- Review validation, calibration, and CSV documentation (IQ, OQ, PQ).
- Train QA auditors and staff on SOPs and regulatory requirements.
- Prepare and review SOPs, training matrices, and job descriptions.
2. Research Associate-I โ Clinical Quality Assurance
Department: Clinical Quality Assurance
Location: Shivajinagar, Wakadewadi, Pune
Qualification: B.Pharm / M.Pharm
Experience: 3+ Years
Vacancies: 2
Key Responsibilities
- Perform in-process audits across clinical study phases.
- Conduct retrospective audits of study reports and eCTD documentation.
- Track and report audit findings and compliance status.
- Support implementation of CAPA and quality improvement initiatives.
- Provide GCP and regulatory compliance training.
- Conduct system and vendor audits.
- Verify QA observations and prepare authentication statements.
- Manage document generation, reconciliation, retrieval, and archival.
- Review calibration and validation records (DQ, IQ, OQ, PQ).
- Perform deviation trend analysis and compliance reporting.
3. Clinical Research Associate (CRA)
Location: Shivajinagar, Pune
Qualification: B.Pharm / M.Pharm
Experience: Minimum 1 Year
Vacancies: 2
Freshers: Not Eligible
Key Responsibilities
- Execute BA/BE studies according to SOPs and regulatory guidelines.
- Prepare and maintain Trial Master Files (TMF), CRFs, and study documentation.
- Review study-related documents for accuracy and compliance.
- Coordinate with bioanalytical and statistical teams.
- Support QA and QC compliance activities.
- Conduct informed consent presentations and participant screening.
- Handle study registration and screening activities.
- Assist in SOP preparation and staff training programs.
- Perform pharmacy-related activities and assigned clinical research tasks.
Eligibility Criteria
Candidates applying for these pharmaceutical and clinical research jobs should possess:
- B.Pharm or M.Pharm degree.
- Relevant experience as per the position applied for.
- Strong understanding of GCP, regulatory guidelines, and clinical research processes.
- Excellent documentation and communication skills.
- Experience in BA/BE studies and quality systems will be preferred.
Why Join Synergen Bio?
- Work with a reputed clinical research organization.
- Exposure to regulatory audits and bioequivalence studies.
- Career growth in Clinical Research and Quality Assurance.
- Opportunity to work on advanced clinical projects.
- Professional development through training and compliance programs.
How to Apply
Interested candidates can share their updated resume at:
Email: careers@synergenbio.com
Important Instructions
- Mention the position applied for in the email subject line.
- Add “Pharma Bharat Candidate” in both the subject line and reference section of your application.
Example Subject Line:
Candidate for CRA Role | Pharma Bharat Candidate
Interview Mode: Face-to-Face
Location: Shivajinagar, Pune