Quality Assurance Manager Jobs in Chennai - Micro Therapeutic Research Labs Pvt LTD
Job Description
- Manager -Quality Assurance
- Qualifications required: B.Pharm / M.Pharm.
- (5-7 years of experience)
- 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 Particulars
Role others
Who can apply Experienced (3+ Years)
Hiring Process Face to Face Interview, Telephonic Interview
Employment TypeFull Time
Job Id413500
Job Category Others
Locality Address
State Tamil Nadu
Country India
About Company
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.
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