Research Associate – Clinical QA/QC (2 Positions)
Location: Chhatrapati Sambhajinagar, Maharashtra
Employment Type: Full-Time
Industry: Pharmaceuticals / Clinical Research
About Wockhardt
Wockhardt is a globally recognized pharmaceutical and biotechnology company dedicated to advancing healthcare through continuous innovation. We are committed to developing life-saving medicines and fostering a dynamic environment where talented professionals can thrive. Join us and contribute to a legacy of excellence in clinical research.
The Opportunity
We are actively seeking two highly skilled and motivated Research Associates to join our Clinical Quality Assurance (QA) and Quality Control (QC) function within our Clinical Research division. This full-time position, based in Chhatrapati Sambhajinagar, Maharashtra, is an ideal opportunity for professionals with a strong background in ensuring the integrity and compliance of clinical trials. You will play a pivotal role in maintaining the highest standards of quality in our groundbreaking research.
Key Responsibilities
- Conduct and provide essential support for Bioavailability/Bioequivalence (BA/BE) studies or Glucose Clamp studies.
- Perform thorough online and retrospective data reviews and audits to ensure accuracy and completeness.
- Ensure strict compliance with all applicable clinical research regulations and guidelines, including Good Clinical Practices (GCP).
- Actively participate in both Regulatory and Sponsor Audits, representing the QA/QC function.
- Maintain meticulous quality documentation and proactively support audit readiness initiatives.
- Ensure rigorous adherence to established Clinical QA/QC procedures and our robust quality management systems.
Qualifications & Skills
- Educational Qualification: M.Pharm is a mandatory requirement.
- Experience: 2–4 years of demonstrated, relevant experience in Clinical Quality Assurance and Quality Control.
- Required Skills:
- Strong understanding of Clinical Quality Assurance (QA) and Clinical Quality Control (QC) principles.
- Proficiency in Clinical Research methodologies, particularly BA/BE and Glucose Clamp Studies.
- Expertise in Data Review, Clinical Auditing, and Regulatory Compliance.
- Experience with Sponsor Audits and comprehensive Documentation practices.
- In-depth knowledge of Good Clinical Practices (GCP).
- Excellent Analytical and Communication Skills.
Why Join Wockhardt?
- Become part of a globally recognized pharmaceutical and biotechnology leader.
- Gain valuable exposure to advanced clinical research methodologies and sophisticated quality systems.
- Play an active role in critical regulatory and sponsor audit activities.
- Work within a professional environment that offers exceptional career development and growth opportunities.
- Make a tangible contribution to innovative healthcare solutions and impactful clinical research programs.
How to Apply
Interested and eligible candidates who meet the specified qualifications and experience are invited to submit their updated CV outlining their relevant expertise.
