Are you an M. Pharm graduate with 2-4 years of experience in Clinical QC/QA? Wockhardt, a leading global pharmaceutical company, is hiring for the position of Research Associate/Senior Research Associate – Clinical QC at its Aurangabad (Chhatrapati Sambhajinagar), Maharashtra location.
This is a fantastic opportunity for professionals looking to advance their careers in clinical quality control and compliance management. If you have expertise in regulatory guidelines (USFDA, EMEA, GCP, NDCT Rules, ICMR), TMF management, and clinical documentation, apply now!
Job Details
- Company: Wockhardt
- Position: Research Associate/Senior Research Associate – Clinical QC
- Location: Chhatrapati Sambhajinagar (Aurangabad), Maharashtra
- Qualification: M. Pharm
- Experience: 2-4 years in Clinical QC/QA
Key Responsibilities
As a Clinical QC professional at Wockhardt, your role will include:
- Ensuring compliance with USFDA, EMEA, GCP, NDCT Rules, and ICMR guidelines
- Managing Trial Master Files (TMF), Clinical Study Reports (CSR), and compliance documentation
- Handling BA/BE studies, clamp studies, and clinical trial protocols
- Reviewing and maintaining SOPs, AE/SAE reports, Informed Consent Forms (ICF), and Case Report Forms (CRF)
- Overseeing IP accountability and pharmacy management
- Preparing and reviewing SOPs, conducting training, and maintaining records
- Assisting in Ethics Committee (EC) submissions, regulatory approvals, and audit processes
Desired Skills & Experience
To excel in this role, candidates should have:
✔ In-depth knowledge of clinical trial regulations (USFDA, EMEA, GCP, NDCT, ICMR)
✔ Experience in TMF management, clinical updates, and compliance
✔ Strong understanding of BA/BE studies and clinical protocols
✔ Proficiency in SOP preparation, document review, and training
✔ Familiarity with IP accountability and pharmacy management
How to Apply?
Interested candidates meeting the eligibility criteria can send their resumes to:
Email: VKakde@wockhardt.com
Don’t miss this opportunity! Apply now and take the next step in your pharmaceutical career with Wockhardt.