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Quality Analyst I - 6014

Date: Jul 12, 2019

Location: Navi Mumbai, IN, 400706

Company: Teva Pharmaceuticals

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

  • Inspect / 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 implemented within the department(s) of WPPL BEC site.
  • Review / update the SOPs, forms, formats and log books of all the department(s) of WPPL BEC prior to their approval and give comments on the same.
  • Perform ‘Document control and issuance’ activities for SOPs, forms, formats, log books, study specific protocols, validation protocols, qualification protocols of all departments of WPPL BEC site. 
  • Plan and execute the inspection and audit, necessary to support the study.
  • Conduct internal study audit, system audits and external contractual audits for compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
  • Review of generated raw data and respective clinical study report, abbreviated clinical study report, CRFs, SERs,  eCTD compilation, review of WinNonlin data, statistical output of clinical study as per the requirement.
  • Ensure periodic review of all quality functions and procedures for appropriateness and validity.
  • Prepare audit report to adhere with the guidelines, written procedures and regulatory inspections.
  • Prepare a compliance report on behalf of the unit, ensure implementation of corrective action and close the audit.
  • Review overall study through inspection of ongoing studies, reports and documentation.
  • Update periodically Quality Manuals of WPPL BEC site.
  • Verify the calibration and maintenance of instruments / Equipment. 
  • Handle the sponsor’s audit / visit at WPPL, BEC site.
  • Resolution of query of regulatory agency or various visitors / auditors.
  • Ensure CAPA actions based on the results of the investigations are identified and implemented.
  • Conduct vendor audit as per scheduled vendor audit plan.
  • Conduct facility audit for studies conducted at WPPL, BEC as and when directed. For instance, prior to a regulatory / sponsor / other inspections.
  • Review of SOPs, Forms and Formats of various departments.
  • Oversee the implementation of managing protocol and SOP deviations.
  • Oversee the implementation of change control procedure.
  • Conduct the quality system training of all staffs.
  • Archiving and maintaining all documents received from various department of WPPL BEC. 
  • Maintain original documents and its distribution records.

To carry out other responsibilities as and when assigned by the Head of Department or designee.

Qualifications

3 - 6 yrs experience

Msc or Mpharma

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.

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