Ensure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products
Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality procedures
Perform impact and risk assessments for critical quality events
Assess and categorize deviations and determine the impact on affected batches
Coordinate with Teva affiliates regarding deviations that may affect product deliveries
Review and evaluate deviation reports from contract manufacturers, assessing their potential impact on the batch release process in collaboration with the responsible Teva release QP
Participate in regulatory inspections, Teva corporate inspections, and internal self-inspections within the scope of responsibility
Collect and analyse quality data and documentation, prepare documentation packages for Quality Alignment Meetings (QAMs) and Market Action Committees (MACs) in accordance with approved templates, and prepare Health Authority (HA) notification letters
Monitor and trend deviations and quality metrics to identify improvement opportunities
Prepare and report KPIs related to quality events and deviation management
Author and maintain local SOPs related to critical quality issues, deviation management, CAPA, and CAPA effectiveness

Experience in pharmaceutical manufacturing/validation/other related experience and/or in analytical control and regulatory compliance
Master’s degree in pharmacy, chemistry, similar natural sciences, engineering or at least several years working experience in the quality assurance area
Understanding of the drug manufacturing process
Knowledge of generics and branded product development is a plus
Good interpersonal and communication skills, as well as organizational skills
Ability to communicate complex issues, decision-making, problem-solving skills
Proficient in written and spoken English
Proficiency in MS Office, SAP, Veeva

Quality Assurance Manager

Key skills