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Manager - Quality Assurance

Micro Therapeutic Research Labs Pvt LTD
4 to 4 Years
25,000 - 35,000 Per Month
Posted on 29 Dec 18
Job DescriptionLast Date 27 Jan 19
  • Overall in charge of quality assurance activities.
  • Periodic independent inspection and audit of facility operations.
  • Periodic review for adequacies of GCP, GLP, SOPs and applicable regulatory compliance.
  • Review of study protocols, Informed Consent Documents (ICDs),SOPs and study reports.
  • Overseeing the training of personnel in GCP, GLP and SOPs.
  • Provide an authenticated signed statement to be included in the final study report.
  • Prepare and submit periodic status report to the management listing observations, deviations and seeking corrective action.
  • Audit of study specific data.
  • Ensure informed consent process has been followed as per guidelines.
  • Ensure adverse event reports available and appropriate action has been taken.
  • Ensure deviations are recorded and authorized. Coordinate with the  external auditors for overall compliance.
  • Oversee the archival and retrieval of documents/records.
  • Sign the outsource service provider agreements.
  • Review and authorize the final study report.
Job Role

Job Type

Interview Type

Face to Face Interview

Company Description
Micro Therapeutic Research Labs Private Limited (MTR) is a quality driven, full service Contract Research Organization (CRO) that provides a broad range of clinical research services to global Pharmaceutical, biotechnology, nutraceutical and cosmetic industry.
At MTR, we operate with state-of-the art research facilities, reduce cycle times for our customers and accelerate the delivery of life -enhancing drugs to market for the benefit of people. We cater to all your needs onbioavailability and bioequivalence studies, clinical research, statistical reporting and data management, etc.,
MTR has some of the leading, most highly regarded experts in their fields. So, you will find that we can understand your goals, develop innovative, tailor-made approaches to streamline your study and make it more cost - effective.

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