Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Position purpose:

The role of the Quality Assurance senior specialist is integral to the production of protein products in adherence to GMP requirements. Senior specialist is responsible for supervising and participating in various activities related to product quality, including conducting detailed assessments and ensuring that the final product meets the quality standards. Additionally, senior specialist actively contributing to the investigation and analysis of deviations and participates in risk management processes.

Responsibilities:

• Developing and maintaining quality assurance documents in compliance with ISO 13485 and GMP requirements. This involves preparing, updating, and reviewing these documents to ensure their accuracy and adherence to relevant standards.
• Actively participating in the company's quality assurance processes, including resolving deviations and customer complaints.
• Ensuring completion and control of GMP records on time in the electronic management system.
• Ensuring the effective implementation of risk management activities by either participating directly or providing mentorship to the team.
• Verifying and approving the accuracy of updated documents within the system. The quality assurance specialist is responsible for conducting detailed checks to ensure that all changes align with the established quality standards and regulatory requirements.
• Printing and issuing protocols for serial production and analysis.
• Coordinating training programs to ensure compliance with GMP requirements. This involves coordinating and facilitating training sessions for employees to improve their understanding of GMP principles and ensure consistent adherence to quality standards.
• Preparing documents for product release. As part of the release process, the quality assurance specialist is responsible for preparing the required documentation. This involves compiling and coordinating all information to ensure release of products to the market.

• Higher university education in molecular biology, chemistry, biochemistry or similar life sciences fields.
• English language communication skills both written and verbal.
• Work experience in a production or research department (would be considered as advantage).
• Project planning and solid understanding of Excel, Word, Access, and quality management software.
• High ethical standards to support a professional business code of conduct.

• Proven experience on requirements of Quality Management System (ISO9001, ISO13485, CFR Part 820) and Good Manufacturing Practice (GMP).
• Well-versed in the development and execution of quality management systems.
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• Work attitude that exhibits drive, creativity, teamwork, assertiveness, good judgment, decision making and ambition.

• The innovative environment of the rapidly growing international company.
• Hard-working, supportive working team and management with outstanding development possibilities to increase your potential.
• Monthly salary 2625 - 3930 Eur (Bruto) and additional benefits package.