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Planning and executing the QA activities for Bioanalytical procedures.
Report on the performance of the quality system to the Head-QAU for review and as a basis for improvement of the system.
Co-ordinate with internal and external parties (Biopharm team) on matters relating to quality system.
Ensure compliance to SOP, GCP / GLP and regulatory guidance’s.
Identify differences in the bioanalytical procedures between site and Lotus and harmonize the SOPs.
Perform Gap assessments for policies and standards and implementation of QMS.
Monitor the bioanalytical projects to ensure that all the data of the bioanalytical phase is audited before submission of study report to sponsor.
Review of raw data of respective method book, method validation, partial method validation study as and when assigned.
Verify equipment installation, qualification, calibration and preventive maintenance in laboratory is conducted as scheduled.
Review of WinNonlin data, statistical output of clinical study as per the requirement.
Conduct external vendor qualification audit and review vendor agreements.
Supervise the archiving process of documents generated by user department during conduct of BA / BE study at site.
Maintain and track Change Control system, deviation and CAPA's.
Conduct system / risk based assessment audit at clinical and pathology laboratory for BA / BE studies conducted at site as and when directed.
Conduct internal study audit, and system audits for compliance with GCP / GLP, Protocols, SOPs and applicable regulatory requirements.
Responsible for handling and managing the archival and retrieval
Review of IT Infrastructure (server, clients systems and software) validation periodically
Support during regulatory and other inspections / audits.
Respond to the regulatory and sponsor’s queries.
Ensure CAPA actions based on the results of the investigations are identified and implemented.
Review / update periodically Policies, Quality Manual, Site Master File at site, and the SOPs and work documents at site prior to their approval and comment on it.
Exp : 9 to 12 years
Function Quality Sub Function R&D Quality
Reports To In process of validation Teva’s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment.
It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.