Cipla is one of the most respected pharmaceutical companies not just in India but across more than 170 countries. Our portfolio includes 2000 products in 65 therapeutic categories with one quality standard globally.
Job Title : Quality Assurance Clinical Trials
Experience : 3 – 4 Years
Location : Mumbai(Lower Parel)
- Responsible for operational compliance of Quality Assurance.
- Responsible for quality assurance of Clinical trials.
- Key role is conducting study specific audits of clinical studies and vendor audits of CRO,
- Data Management, Central labs etc.
- Implementing and maintaining an effective audit program.
- Development of standard operating procedures.
- Responsible for issuance, retrieval & archival of SOPs.
- Monitoring corrective action plans through use of existing processes e.g. CAPA.
- Consulting with auditees on development and implementation of effective resolution of compliance issues.
- Monitoring regulatory compliance trends and modifying audit program accordingly.
- Responsible for training of the staff (monitors, project managers, Investigators, CTPs, CTAs CRAs etc) as per the internal SOPs and regulatory requirements.
- Responsible for training of SOPs & others procedures.
- Tracking completion of agreed upon corrective actions as a result of audit and regulatory Inspection commitments.
- Conducting project specific audits.
- Review of study initiation, monitoring and close out visit reports, thank you letters & follow up letters.
- Review of study Protocol/ ICF/ CRF/ SAEs/ CSR.
- Responsible for Quality Assurance of packaging and labelling of investigational product.