Quality Assurance Specialist

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

As an Quality Assurance Specialist, you play a meaningful role in maintenance and continual improvement of the quality system, in order to ensure compliance with the regulations and Roche requirements, and an uninterrupted supply of quality products to the patients.

This is a contractor position for a determined period of time until the 31st of December 2025. Your employer will be a third-party supplier, in service for Roche.
 

Key responsibilities

• Maintain the Quality System and ensure an uninterrupted supply of the products to the market
• Release commercial product batches to the local market and Investigation Medicinal Products to the local clinical investigation centers, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
• Follow GDP guidelines and regulations for the products distributed locally
• Involved in local redressing process
• Follow batch traceability for all batches received and distributed by the local warehouse
• Provide appropriate supervision of the supply chain, and existence of additional controls for the cold chain
• Documentation management – ensures the records management requirements of any performed tasks are according to Good Documentation Practices (ALCOA principles)
• Involved in managing complaints, recalls and returns
• Dealing with internal and external inquiries about the products quality
• Back up for the Local Logistic Security Officer Role
• Follow security protocols, risk assessments, and coordinating with various stakeholders to ensure compliance with safety standards.

Who you are

• University degree in  Pharmacy or related field
• Proficiency in English and Macedonian (both written and spoken)
• 3 years’ experience in the areas of Quality Control and/or Quality Assurance is desired
• Analytical and problem solving skills
• Sense for quality assurance and details.
• Ability to work as part of a team.
• Strong verbal and written communication skills. 
• Well-organized, detail oriented professional and ability to prioritize and make decisions. 
• Highly self-motivated; able to lead initiatives with authority.
• Knowledge of working in SAP / other ERP system is an advantage 
• Advanced proficiency with Microsoft Office Tools (Excel, Power Point, Word)
• Valid driving license