Quality Analyst I Job Vacancy in Teva Pharmaceuticals Mumbai, Maharashtra – Updated today
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Company Name : Teva Pharmaceuticals
Location : Mumbai, Maharashtra
Position :
Job Description : Company Info
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description
Candidate with experience of BizNET software application & its clinical data management.
Testing of deployment for BizNET CTMS and verifying with URS
Experience with preparation & review of BizNET CTM SOPs.
Experience with designing of e- CRF and screening forms for clinical studies.
Training of BizNET CTM applications to Users.
To monitor and perform Quality Check of all study activities from check-in, dosing, sample collection, processing, segregation, transfer and till checkout.
Co-ordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.
Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.
Coordinate with the Ethics Committee for submission of protocol and other study related documents.
To perform QC of ICF, compensation chart and review of CRF (versus Protocol), other study related documents prior to EC submission.
Handling of monitor’s visits, maintaining of site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.
Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
Any discrepancies/ Deviations to be informed to Team Leader and Manager (if Required).
Ensuring quality by reviewing all study related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study close out report, Sample Case record form, Study updates, screening examination record.
Full participation in internal and external audits by sponsors and other oversight entities such as FDA, EU, ANVISA.
Review of SDTM & Clinic tables data with the source document.
To verify the calibration and verification of instruments/equipment.
Qualifications
Education: B. Pharm, M. Pharm or M.Sc. (Clinical Research) or any post graduate.
Experience: At least 1- 6 years of experience as a Clinical Research Coordinator in reputed BA/BE centre.
Function
Quality
Sub Function
R&D Quality
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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.
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