Job Description The job would entail :
* Continued maintenance of a clinical QA System with written standard operating procedures (SOPs) * Preparation of quality assurance department SOPs* Coordinating with clinical operations personnel for implementing the SOPs, compliance with GCP and regulations in the conduct of clinical research * Conduct of quality reviews of protocols, CRFâs, clinical study reports and supplemental study documentation.* Quality audits of tables, data listings, and study reports for data management projects* Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and regulatory requirements * Imparting training to clinical operations personnel on GCP and regulations in Clinical research* Identification of areas for continuous quality improvement and leading the organization in implementing these improvements* Communication with management about quality issues or problems* Interfacing with regulatory agency, sponsors and independent internal auditors.
Desired Profile
Candidate must have B. Pharma/ M. Pharma/ MBBS/ Graduation or Post graduation in any stream of life science
Experience 1 - 2 Years
Contact : Vishwani Dev LUPIN LIMITED
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