Rusan Pharma Ltd is a well-established pharmaceutical company located in Gandhidham, Gujarat. Known for its commitment to quality and regulatory excellence, Rusan Pharma is seeking a dedicated Auditor/Research Associate to contribute to the quality assurance of clinical and bioanalytical studies.
Job Details
- Position: Auditor/Research Associate
- Job Type: Full-time
- Shift: Day shift
- Location: Gandhidham, Gujarat
Key Responsibilities
- Quality Assurance Program: Implement and manage the GCP/GLP quality assurance program to ensure BA/BE and clinical studies meet regulatory requirements.
- Regulatory Inspection Support: Assist with GCP/GLP inspections by regulatory bodies such as USFDA, WHO, ANVISA, and facilitate second-party sponsor audits.
- SOP Management: Oversee the generation, distribution, retrieval, and archival of SOPs, including maintaining records, logbooks, and master lists.
- Document Archiving: Ensure the archiving of study-related documents and electronic data in accordance with OECD and applicable regulatory guidelines.
- Quality Assurance Plans: Develop and implement QA plans for clinical and bioanalytical studies.
- Audits: Conduct regular audits to verify compliance with regulatory standards and protocols.
- Document Review: Review clinical study documentation, such as study protocols, case report forms, and consent forms.
- Bioanalytical Study Review: Review documentation related to bioanalytical studies, including method SOPs and sample analysis plans.
- Vendor Audits: Conduct both onsite and offsite vendor or third-party audits.
- Regulatory Compliance: Ensure clinical trials adhere to GCP, applicable SOPs, and regulatory guidelines.
Qualifications and Skills
- Education: Minimum Bachelor’s degree in Pharmacy or Life Sciences.
- Knowledge:
- GCP and ICH guidelines.
- ISO 9001:2015 quality management system.
- FDA regulations and relevant regulatory guidance for bioequivalence and clinical trials.
- Experience: Familiarity with managing quality assurance programs, conducting audits, and understanding clinical and bioanalytical documentation.
How to Apply
Interested candidates are encouraged to submit their resumes to bhavashree.patil@rusanpharma.com.
