Teva Senior QA Specialist 

Romania, Bucharest 

54717038

• 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.

• Fluent verbal and written communication in English
• Ability to simplify processes, identify bottlenecks and translate stakeholder feedback into clear processes.
• Active listener and decision-making skills.
• Team role player with strong analytical and critical thinking approach.
• Knowledge on OPEX and implementation of time management tools (i.e. Daily Tier meetings, workplan boards).

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