Quality Assurance Associate

Responsibilities:

• Manage and handle Quality Technical Agreements (QTA).
• Conduct thorough investigations of deviations and customer complaints, ensuring comprehensive documentation and resolution.
• Oversee supplier qualification activities, maintaining updated and compliant records.
• Process and document change controls, coordinating with relevant stakeholders to ensure adherence to procedures.
• Review batch documentation thoroughly for product release, ensuring compliance with regulatory requirements.
• Participate actively in risk management processes, identifying potential risks and recommending mitigation strategies.
• Initiate and follow up on Corrective and Preventive Actions (CAPA) ensuring their timely implementation and effectiveness.

Qualifications:

• Bachelor's degree in life sciences or a related field; a degree in Pharmacy is highly preferred.
• A minimum of 1 year of relevant experience in GMP and Quality Management Systems (QMS).
• Strong knowledge and understanding of EU GMP guidelines (EudraLex).
• Proficiency in English, including excellent speaking, reading, and writing skills.

Area of responsibilities:

• Belarus
• Serbia

Personal Attributes:

• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Highly organized with attention to detail.
• Ability to work independently and collaboratively within a team environment.