Synergen Bio Hiring Clinical QA Auditors

Clinical QA Auditor | Synergen Bio | Pune Pharma Careers

Synergen Bio hiring Clinical QA Auditors (B.Pharm/M.Pharm/MSc) in Pune. 2-4+ yrs experience. Immediate joiners preferred. Apply now!

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Synergen Bio, a leading clinical research and pharmaceutical quality services provider, is inviting applications for the role of Clinical QA Auditor at its Pune office. This is an excellent opportunity for experienced professionals with a B.Pharm, M.Pharm, or MSc qualification to advance their careers in clinical quality assurance, regulatory compliance, and clinical research auditing. Candidates with 2-4+ years of experience and a passion for ensuring compliance and quality excellence are encouraged to apply immediately.

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Company Overview

Synergen Bio is a globally recognized clinical research organization (CRO) and pharmaceutical quality services company, specializing in clinical trial management, quality assurance, and regulatory compliance. With a strong emphasis on patient safety, adherence to global standards, and accurate clinical data management, Synergen Bio has become a trusted partner for pharmaceutical sponsors and healthcare organizations worldwide.

The company is committed to scientific excellence, operational efficiency, and continuous improvement. By employing cutting-edge tools, robust quality management systems (QMS), and skilled professionals, Synergen Bio ensures regulatory compliance and high-quality outputs in clinical trials.

Why Work at Synergen Bio:

• Exposure to end-to-end clinical quality assurance processes.

• Hands-on experience in clinical trial audits, eCTD compilation, and regulatory compliance.

• Collaborative environment with cross-functional teams and international clients.

• Opportunities to lead audits, train QA staff, and recommend process improvements.

• Contribute directly to enhancing patient safety and data integrity in clinical trials.

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Job Role & Responsibilities

As a Clinical QA Auditor, you will play a critical role in ensuring the integrity, accuracy, and compliance of clinical trial processes and documentation. Key responsibilities include:

• Project Management:

  • Manage project timelines and deliverables efficiently.

  • Ensure effective work distribution across the team.

  • Coordinate with cross-functional departments to meet deadlines.

• In-Process Clinical Audits:

  • Conduct audits of ongoing clinical study phases.

  • Verify adherence to study protocols, SOPs, and regulatory requirements.

• Retrospective Audits:

  • Plan and execute audits of historical clinical data.

  • Ensure compliance with regulatory guidelines and internal SOPs.

• Documentation Review:

  • Review study protocols, Clinical Study Reports (CSRs), eCTD submissions, Module 2.7.1, and DBE Summary Tables.

  • Verify accuracy and completeness of clinical documentation.

• System and Vendor Audits:

  • Conduct audits of clinical research systems for compliance.

  • Perform vendor audits of external service providers and recommend qualification status to management.

• Equipment & Validation Compliance:

  • Review validation, calibration, and maintenance documents of instruments and equipment.

  • Ensure compliance with established quality standards.

• Training & Mentorship:

  • Train QA auditors and staff on in-house SOPs, quality systems, and regulatory guidelines.

• Process Improvement:

  • Recommend enhancements to quality management systems (QMS).

  • Address deviations, change controls, CAPA, and other process improvement initiatives.

Key Outcomes:

• Maintain compliance with regulatory standards (ICH-GCP, FDA, EMA).

• Enhance quality assurance processes across clinical studies.

• Ensure accurate, reliable, and audit-ready clinical documentation.

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Eligibility / Qualifications

Candidates applying for the Clinical QA Auditor role must meet the following criteria:

• Educational Qualification:

  • B.Pharm, M.Pharm, MSc in Life Sciences, Pharmaceutical Sciences, Clinical Research, or related fields.

  • Relevant courses include: Clinical Research, Pharmaceutical Quality Assurance, Regulatory Affairs, Pharmacology, Biostatistics, Pharmaceutics, Drug Development, Clinical Trial Management.

• Experience: 2-4+ years in clinical QA, clinical audits, or regulatory compliance.

• Skills & Competencies:

  • Strong understanding of GCP, ICH, and regulatory guidelines.

  • Experience in clinical audits, eCTD compilation, and quality systems.

  • Excellent documentation and reporting skills.

  • Ability to train staff and mentor junior auditors.

  • Strong analytical, problem-solving, and organizational skills.

  • Attention to detail and ability to work under deadlines.

High-CPC Keywords Targeted: Clinical QA jobs, pharma QA auditor careers, clinical research auditor, quality assurance in clinical trials, GCP compliance jobs, regulatory affairs auditor, Pune pharma jobs.

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Location & Salary

• Job Location: Pune, Maharashtra

• Department: Clinical Quality Assurance

• Vacancy: 2

• Experience Required: 2-4+ years

• Salary: Competitive, based on experience and industry standards (details provided during interview)

Why Pune for Pharma Careers: Pune is a major hub for pharmaceutical companies, CROs, and clinical research organizations, offering exposure to cutting-edge clinical trials, regulatory compliance projects, and QA management systems.

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Application Process

Step 1: Prepare Your Application

• Updated Resume highlighting educational qualifications, clinical QA experience, and audit exposure.

• Certificates of B.Pharm, M.Pharm, or MSc.

Step 2: Apply via Email

• Submit your CV to careers@synergenbio.com.

• Use the subject line: “Application for Clinical QA Auditor – Pune”.

Step 3: Screening & Interview

• HR and QA Management will shortlist candidates based on experience, qualifications, and skill set.

• Shortlisted candidates will be contacted for interviews or technical assessments.

Step 4: Join Synergen Bio

• Immediate joiners are preferred.

• Successful candidates will receive joining instructions and onboarding details.

CTA Optimization:

Apply now to join Synergen Bio, Pune, as a Clinical QA Auditor and advance your career in clinical research quality assurance and regulatory compliance. Immediate joiners get priority consideration!

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Why Choose Synergen Bio

• Industry Credibility: Synergen Bio is a trusted CRO and QA services provider with a strong track record in clinical research compliance.

• Global Exposure: Work on international clinical trial projects and regulatory audits.

• Professional Growth: Structured career paths in clinical QA, regulatory affairs, and compliance management.

• Impactful Contribution: Ensure patient safety, accurate data management, and regulatory adherence in clinical trials.

• Fresher & Experienced Roles: Opportunities for mentorship, training, and process improvement initiatives.

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FAQ Section

Q1. Who can apply for the Clinical QA Auditor role?
A: Candidates with B.Pharm, M.Pharm, or MSc and 2-4+ years experience in clinical QA or auditing.

Q2. Is immediate joining mandatory?
A: Immediate joiners are preferred, but candidates with short notice periods may also apply.

Q3. What documents are required for application?
A: Resume and academic certificates (B.Pharm/M.Pharm/MSc).

Q4. Where is the job location?
A: Pune, Maharashtra, India.

Q5. How many vacancies are available?
A: 2 positions for Clinical QA Auditors.

Q6. What is the application process?
A: Submit CV via careers@synergenbio.com, followed by screening and interviews.

Q7. What career growth opportunities exist?
A: Growth from Clinical QA Auditor → Senior QA Auditor → QA Lead → QA Manager → Regulatory Affairs Lead.

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