Quality Analyst - Fixed Term Contract
Bucharest, Romania, 011171
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
As a Quality Specialist you will be responsible of implementing and maintenance of Good Manufacturing Practice (GMP) compliance, batch certification, and review of quality system documentation.
How you’ll spend your day
• 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 for the site: Required knowledge about ALCOA+ and DI principles (such as data protection, segregation of duties, audit trail).
• Contribute to the Implementation and maintenance of Quality Management Systems (CAPA, Complaints, Deviations/Out-of-Specification, Change control System Organization): Required 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 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.
Your experience and qualifications
• Fluent verbal and written communication in English and preferably additional other languages (i.e French, Italian, Spanish)
• Ability to simplify processes, identify bottlenecks and translate stakeholder feedback into clear processes.
• Active listener and decision-making skills.
• Teamplayer with strong analytical and critical thinking approach.
• Knowledge on OPEX and implementation of time management tools (i.e. Daily Tier meetings, workplan boards).
• Minimum 2 year experience on Quality Unit in Pharma Industry or minimum 5 years experience in Quality Control laboratory or in production is required.
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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
