Senior QA Specialist

Who we are

Sindan, part of Teva Group, is a pharmaceutical company dedicated to oncology treatments, founded in 1991, within the structure of the Research Department of the Bucharest Oncology Institute. In 2000, Sindan was certified according to Good Manufacturing Practice quality standards and currently delivers products to over 75 countries worldwide.

In March 2006, the Icelandic group Actavis bought Sindan and in 2016, Teva acquired the generics division (Actavis Generics) of the global manufacturer Allergan (same year, Sindan became part of Teva group).

Following this global acquisition, Teva's portfolio in Romania expanded by taking over the oncology drug factory intended for both domestic consumption and export – Sindan Pharma.

Teva is a global leader in the pharmaceutical industry with a portfolio of over 3,500 products in over 60 countries. Every day, nearly 200 million people around the world take a Teva medicine.

Since Teva was founded in 1901 in Jerusalem, our way of working has been shaped by people who have remained faithful to our humble beginnings. Our leadership has been driven by tenacity, entrepreneurial spirit and ambition to improve people's lives.

Currently, Teva covers the treatment needs of hundreds of thousands of patients in Romania with an extensive portfolio of generics, innovatives, OTC and cosmetic medicines, intended for the following therapeutic areas : Neurology, Psychiatry, Hematology, Respiratory, Oncology, Cardiology, Infectious Diseases, Pain, Endocrinology.

Teva Romania objective is to remain a company with an extensive and diversified portfolio, which responds to currently unmet therapeutic needs through new products to be launched in the innovative portfolio and not only.

Main Job responsibilities

• Inspection Readiness : Manage and support regulatory inspections as a team member / SME or lead auditor in conducting audits (internal or external) including preparation of audit report responses to authorities. Participate actively in Shopfloor Quality oversight program. Required experience in EU / FDA regulatory inspections.
• Data integrity champion for the site : Required knowledge about ALCOA+ and DI principles (such as data protection, segregation of duties, audit trail).
• Oversight and Implementation of Quality Manamgement Systems (CAPA, Complaints, Deviations / Out-of-Specification, Change control System Organization) : Requiered experience with Veeva and TrackWise systems.
• Organization, Approval and Verification of the corrective and preventive actions, complaint, deviations, out-of-specification results and change control system
• Monitoring the timely and correct implementation of corrective and preventive actions proposed as a result of process deviations, controlled changes, or non-conformities identified during internal / external audits.
• Verification of the effectiveness of corrective / preventive actions or issuance of a protocol to determine their effectiveness
• Investigation of quality-related complaints, including corrective and preventive actions
• Identify Quality Deficiencies, report to Senior Quality Unit Management and ensure are resolved in a timely manner, in accordance with internal procedures.
• Support for Other Departments in Quality Assurance Activities to ensure compliance.
• Issuance, verification, and / or approval of documentation related to the compliance with corporate standards and verification of documents according to current procedures (master OPs, standard operating procedures, controlled changes, deviations, risk assessment sheets, investigation reports, quality specifications, analytical methods).
• Prepare, analyze and communicate quality metrics to the site leadership and above site functions.
• Active role in communicate findings and sharing best practices for continuous improvement.

Skills