Synergen Bio – Career Opportunity for Clinical QA Auditors
Synergen Bio, a leading name in clinical research and pharmaceutical quality assurance, is inviting passionate professionals to join its expanding team. The company is offering an exciting job opportunity for the position of Clinical QA Auditor at its Pune location.
With a strong presence in the field of clinical research auditing, Synergen Bio is known for upholding the highest standards of regulatory compliance, data integrity, and quality management across all its projects. If you’re a driven professional seeking a rewarding role in clinical quality assurance, this opening is the perfect fit.
About Synergen Bio
Synergen Bio is a reputed organization committed to excellence in biopharmaceutical research, clinical trials, and quality systems. The company collaborates with global pharmaceutical and biotech organizations to deliver compliant, efficient, and ethical research services.
Its success is built on a foundation of scientific expertise, process integrity, and adherence to international regulatory guidelines such as ICH-GCP, USFDA, and EMA standards. With a skilled team of professionals and cutting-edge infrastructure, Synergen Bio ensures that every clinical project meets the highest benchmarks of quality, safety, and accuracy.
Visit the official website Synergen Bio to learn more about the company’s services and mission.
Position Overview
Position: Clinical QA Auditor
Qualification: B.Pharm / M.Pharm / M.Sc
Experience: 2 to 4+ years
No. of Vacancies: 02
Job Location: Pune, Maharashtra
Note: Immediate joiners preferred
This role offers an excellent opportunity for experienced professionals looking to grow in the domain of Clinical Quality Assurance and contribute to global research excellence.
Role & Responsibilities
The Clinical QA Auditor plays a vital role in ensuring compliance, quality, and regulatory integrity across ongoing and completed clinical studies. The key responsibilities include:
1. Project Management and Coordination
Manage project timelines and ensure effective work distribution within the QA team.
Coordinate with cross-functional departments to achieve project deliverables.
Organize team training sessions to maintain audit readiness and compliance awareness.
2. Conduct of In-Process and Retrospective Audits
Perform in-process audits of ongoing clinical trials to verify adherence to protocols, SOPs, and GCP guidelines.
Plan and conduct retrospective audits of clinical raw data, ensuring compliance with regulatory frameworks and company SOPs.
3. Review and Documentation
Review study protocols, Clinical Study Reports (CSRs), eCTD compilations, and DBE summary tables.
Ensure that documentation meets the requirements of regulatory authorities and internal standards.
4. System and Vendor Audits
Execute system audits of clinical research operations to verify compliance.
Conduct vendor audits for external service providers, review audit reports, and recommend qualification status to management.
5. Instrument Validation and Calibration
Review validation and calibration documents of instruments and equipment used across departments.
Ensure that calibration and qualification records meet industry standards and QA protocols.
6. Quality System Implementation
Implement and monitor Quality Management Systems (QMS), including Deviation, Change Control, and CAPA management.
Recommend process improvements to enhance quality standards and minimize operational errors.
7. Training and Development
Conduct regular training sessions for QA auditors and staff on SOPs, quality systems, and regulatory requirements.
Foster a culture of continuous improvement and compliance within the QA department.
Qualifications and Experience
To qualify for the Clinical QA Auditor position at Synergen Bio, candidates should possess:
A degree in B.Pharm, M.Pharm, or M.Sc in Life Sciences or Pharmacy.
2 to 4+ years of experience in clinical research auditing, GCP compliance, or quality systems management.
Strong knowledge of regulatory guidelines such as ICH-GCP, USFDA, MHRA, and EMA.
Ability to conduct independent audits, prepare comprehensive reports, and manage timelines effectively.
Excellent communication, analytical, and documentation skills.
Preferred Candidate Profile
Synergen Bio is seeking professionals who are:
Detail-oriented with a strong understanding of clinical trial documentation.
Experienced in managing internal and external audits.
Capable of working in a fast-paced, compliance-driven environment.
Immediate joiners with a proactive approach to quality improvement and data integrity.
Why Join Synergen Bio?
Joining Synergen Bio offers you the chance to be part of an organization that values quality, ethics, and innovation. The company encourages continuous professional development, providing employees with opportunities to grow through training programs, audit exposure, and cross-functional learning.
Key Benefits of Working at Synergen Bio
Exposure to international clinical research projects.
Opportunity to collaborate with leading scientists and quality experts.
Supportive environment fostering career advancement and skill enhancement.
Competitive compensation and a culture that rewards excellence and accountability.
By working as a Clinical QA Auditor, you’ll play a crucial role in ensuring that all clinical research processes at Synergen Bio meet the highest global quality standards.
How to Apply
Interested candidates who meet the eligibility criteria are encouraged to apply immediately.
📩 Send your updated CV to: [email protected]
Make sure to include details of your:
Educational qualifications
Relevant experience
Notice period and current CTC
Immediate joiners will be given preference during the selection process.
Career Growth Path
As part of Synergen Bio’s QA team, professionals can progress through a clearly defined career trajectory—from QA Auditor to Senior Auditor, QA Manager, and eventually into Global Quality Leadership roles.
Continuous exposure to regulatory audits, clinical trials, and GxP environments ensures that employees gain valuable expertise that enhances their professional credibility in the global market.
Conclusion
The Clinical QA Auditor position at Synergen Bio is an outstanding opportunity for professionals passionate about ensuring quality, compliance, and data integrity in clinical research.
Located in Pune, this role offers an engaging work environment, professional growth, and the satisfaction of contributing to research that improves global healthcare outcomes.
If you are ready to take the next step in your Quality Assurance career, Synergen Bio welcomes you to apply today and join its mission to drive excellence in clinical research.
Frequently Asked Questions (FAQs)
1. What is the job location for the Clinical QA Auditor position at Synergen Bio?
The position is based in Pune, Maharashtra, at Synergen Bio’s clinical operations facility.
2. What qualifications are required for this role?
Candidates must hold a B.Pharm, M.Pharm, or M.Sc degree with 2–4+ years of experience in clinical research or quality assurance.
3. How can I apply for this opportunity?
Interested candidates can share their updated resumes via email at [email protected]. Immediate joiners are preferred.
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