Clinical Quality Control Specialist

Teva Pharmaceutical Industries Ltd.
Experience : Freshers
Education : Any Graduate
Location : Navi Mumbai
Job Role : Others
Posted on 27 Feb 20
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Job DescriptionLast Date 27 Apr 20
Clinical Quality Control Specialist

Location: Navi Mumbai, IN, 400706

Job Description :

  • Retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements.
  • 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
  • Monitoring of SAE and AE management and reporting to all applicable bodies (Regulatory, Ethics committee, Sponsor and PVPI team.)
  • Ensuring compliance of standard operating procedures, regulatory guidelines and all applicable laws
  • Review of SDTM & Clinic tables data with the source document.
  • Quality Control of study activities such as IP dosing, sample collection, sample separation, sample segregation, verification and sample transfer for all clinical studies
  • Plan and conduct general in-house audits of facility areas like pharmacy, screening, clinic ward, ICU
  • Ensure that the processes needed for Quality management system are established, implemented and maintained.
  • To verify the calibration and verification of instruments/equipment.
  • To coordinate with the user department and medical writing department for clinical study reports.
  • Quality Review of protocol & Informed consent forms by referring the available literature for the drug molecule.
Qualifications : BSc / Msc Clinical Research, 2yrs Relevant Experience.
Job Type : Full Time
Interview Type : Face to Face Interview
Company Description
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.
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