Quality Assurance Manager

Role Overview

• 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.

Requirements

• 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

Benefits

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria.
• Competitive remuneration bound with performance.
• Additional healthcare insurance.
• Transportation allowance.
• Flexible working hours and option to work from home as per the company policy.
• Opportunity for development