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65 Watson Pharama Jobs
Quality Analyst I
Watson Pharama
posted 5hr ago
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Fixed timing
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Job Description
Find a Career With Purpose at Teva
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Select how often (in days) to receive an alert: Quality Analyst I Date: Feb 10, 2025
Location:
Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 60702
Who we are
How you ll spend your day
- Audit Bioanalytical phase of BA/BE studies 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 the SOPs, forms, formats and logbooks of all the department(s) and give comments on the same.
- To review the change control and deviations as and when assigned.
- Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections and ensure compliance from user department to audit reports.
- To review method SOP s as and when assigned.
- Conduct in-process study audit in order to ensure the compliance to GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
- 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.
- To share QA audited concentration data to Biostatistician as per business timelines.
- To audit of PK and statistical output of clinical study as per the requirement.
- To audit Bio-summary tables (OGD), eCTD compilation of clinical studies.
- Review overall study through audit of ongoing studies, reports and documentation and release the study specific audit certificate.
- To co-ordinate with user department and medical writer for finalization of bioanalytical reports and clinical study reports.
- Review of audit trail on LC-MS/MS instrument.
- To conduct area specific audit, system audits and vendor audits as and when assigned.
- To audit calibration records/ qualification records of instruments/equipment s for bioanalytical as and when assigned.
- Control and issue the documents i.e. SOPs, forms, formats, logbooks, study specific protocols, validation protocols, and qualification protocols of all departments of WPPL.
Your experience and qualifications
- B.Pharm, M.Pharm OR M.Sc
- 3-6 Years of experience into Bioanalytical Quality Assurance for a BABE Study
Teva s Equal Employment Opportunity Commitment
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
Within city
Day Shift
Watson Pharama Benefits
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