About the Company :
The firm is an MNC distributed over more than 80 countries serving more than 200 million people. The company working on patient centric giving efforts to produce the high standard medicines. The firm is based on Israel and works mainly on generics.
About the Job :
Experience : B. / M. Pharma with 3-6 years of experience in quality function
Roles & responsibility :
- Able to control and issue the documents i.e. SOPs, forms, formats, log books, study specific protocols, validation protocols, qualification protocols of all departments of BEC site as per SOP.
- Should provide audit certificate after completion of review of Clinical study report and QA statement for Method validation & Bioanalytical report as per SOP.
- Effective handling of audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports.
- Capable to co-ordinate with user department and medical writer for finalization of bioanalytical reports and clinical study reports.
- Present and co-ordinate in-process study audit in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
- Review the Audit of generated raw data and respective validation report, addendum, bioanalytical report generated from method validation, partial method validation, subject sample analysis of clinical study.
- Quickly share QA audited concentration data to Biostatistician.
- Provide audit of PK and statistical output of clinical study as per the requirement, To audit Bio summary tables (OGD), eCTD compilation of clinical studies.
- Need to Conduct vendor audit as per scheduled vendor audit plan as per SOP.
- Capable to review overall study through audit of ongoing studies, reports and documentation.
- Need to audit each BA/BE studies (both pre and post study) to assure the management that the facilities, personnel, equipment, instruments, protocols, methods, practice, records and controls are in conformance with the relevant and current GCP / applicable GLP guidelines, protocols and SOPs.
- Review of audit trail on LC-MS/MS instrument as per SOP.
- Able to manage and Assist to handle the sponsor’s audit / visit and assist in responding to queries as and when required.
- Collect and review of Instruments/Equipment/Software Qualification, Calibration and Validation records as per SOP