Synergen Bio Private Limited, a DCGI (CDSCO)-approved Contract Research Organization (CRO) based in Pune, is hiring a Quality Assurance Head (QA) for its facility in Shivajinagar, Wakadewadi.
Established in 2018 by a team of passionate professionals, Synergen Bio is known for its expertise in clinical research, bioanalytical studies, and BA/BE trials, serving pharmaceutical and biotech industries globally. Join a dynamic CRO committed to quality, knowledge, and cost-effective solutions
About Synergen Bio Pvt. Ltd.
Headquartered at Old Mumbai-Pune Hwy, Wakadewadi, Shivajinagar, Pune, Synergen Bio operates a modern facility supporting Phase I-IV clinical trials, BA/BE studies, and data management. With over 30 clinical research projects in areas like oncology, hepatology, and cardiology, the company is DCGI-approved and adheres to GCP and GLP standards.
Rated 3.9/5 on AmbitionBox based on 65+ reviews, employees praise the company culture (4.0/5) and supportive management but note concerns about job security (3.9/5) and short lunch breaks (35 minutes). Salaries range from ₹1.4L for trainees to ₹5.7L for senior roles, with a 1-month notice period for most (36%).
Job Details: Quality Assurance Head (QA)
- Position: Quality Assurance Head
- Qualification: M.Sc, B.Pharm, M.Pharm
- Experience: 15+ years in QA (pharma/CRO, preferably in bioanalytical/clinical research)
- No. of Vacancies: 1
- Note: Immediate joiner preferred
- Work Location: Shivajinagar, Wakadewadi, Pune, Maharashtra
- Posted: June 2025 (based on user input)
Responsibilities
- Plan and conduct system audits for Bioanalytical, General Admin, Biostatistics, Project Management, Biopharmaceutics, and IT departments per schedule; prepare audit reports and ensure compliance
- Ensure systems adhere to SOPs, protocols, GCP, GLP, and local regulatory guidelines (e.g., DCGI, USFDA, EMA)
- Review SOPs, protocols, reports, and CAPA plans for client and regulatory audits
- Oversee in-process and retrospective audits in clinical and bioanalytical research departments
- Ensure all studies comply with protocols, SOPs, and regulatory standards
- Manage project timelines, work distribution, training, and method validation coordination
- Review validation and calibration data for instruments/equipment across departments
- Design process improvements to enhance quality and minimize errors
Required Skills
- Expertise in QA auditing for bioanalytical and clinical research (BA/BE studies)
- In-depth knowledge of GCP, GLP, USFDA, EMA, and ICH guidelines
- Proficiency in SOP/protocol development, review, and QMS (CAPA, deviations)
- Strong leadership, project management, and inter-departmental coordination skills
- Experience with instrument validation (e.g., LC-MS/MS, HPLC) and regulatory audits
- Ability to implement process improvements and handle tight timelines
- Excellent documentation and analytical skills
Application Details
- How to Apply: Email your resume to careers@synergenbio.com with the subject “Application for Quality Assurance Head – Pune – June 2025.”
- Contact: Not specified; use email for queries
- Website: www.synergenbio.com
- Application Deadline: Not specified; apply by June 20, 2025, for priority
Verified by Trusted HRs
The post is released by the Synergen Bio LinkedIn page. Click here to visit the post
Documents Required:
- Updated resume with passport-sized photograph
- Copies of M.Sc/B.Pharm/M.Pharm certificates and mark sheets
- Aadhaar Card and PAN Card
- Experience certificates or relieving letters
- Last 3 months’ payslips and CTC breakup
- Note: Immediate joiners preferred (within 15–30 days)
Why Join Synergen Bio?
Synergen Bio offers a challenging yet supportive environment for QA professionals, with opportunities to lead quality initiatives in a DCGI-approved CRO. Employees benefit from:
- Learning Opportunities: Exposure to BA/BE studies and global regulatory standards (4.0/5 for culture)
- Supportive Management: Collaborative seniors and flexible timings (alternate Saturdays off)
- Benefits: Timely salaries (3.9/5), learning-focused environment, and desk-based role However, concerns include limited career growth (3.8/5), short lunch breaks, and occasional job security issues. The average QA salary at Synergen Bio is estimated at ₹5–13.85L/year for senior roles, with top 1% earning above ₹13.85L. Join a CRO with a vision to be a premium research partner
Why Shivajinagar, Wakadewadi, Pune?
Synergen Bio’s facility is strategically located opposite the Bajaj Showroom on Old Mumbai-Pune Hwy, in Pune’s research hub. Shivajinagar offers excellent connectivity, but traffic may require personal transport. Pune’s vibrant ecosystem supports a high quality of life, with affordable living compared to Mumbai.
Important Notes
- Eligibility: Only candidates with 15+ years of QA experience in pharma/CRO (bioanalytical/clinical research preferred). M.Sc/B.Pharm/M.Pharm required.
- Work Environment: Desk job with occasional travel within city/country for audits. Alternate Saturdays off with strict timings.
- Disclaimer: Synergen Bio does not charge fees for job applications. Use only official contact careers@synergenbio.com. Beware of fraudulent offers.
- Note: Candidates interviewed in the last 6 months need not reapply. Expect a high-pressure role with significant responsibility but strong learning potential.
Don’t miss this opportunity to lead QA at Synergen Bio Pvt. Ltd.! Email your resume to careers@synergenbio.com by June 20, 2025, and drive quality in clinical research in Pune!
