Do you want to join one of Norway's fastest growing biotechnology companies?

GMP Specialist

Born from the unique conditions of the Arctic - ArcticZymes Technologies is a biotechnology company selling cold-adapted enzymes and enzyme solutions to industrial customers in a global market. Through collaboration and partnership, the company has more than 30 years of experience in developing unique and high-quality enzymes - enabling new solutions and technology development within molecular biology research, diagnostics and biopharmaceutical manufacturing.

The company is growing fast and currently has about 60 employees located in Europe, USA and Asia with main office, R&D and production, in Tromsø. Our growing product portfolio and increased requirements for quality assurance, means that ArcticZymes Technologies are expanding, and we are looking for a highly motivated GMP Specialist to join us to help accelerate our growing business in our QA and Regulatory Department.

GMP Specialist

As a GMP Specialist for ArcticZymes Technologies, you will be responsible for providing expert review of a wide range of GXP documentation (e.g., Standard Operating Procedures, Batch Manufacturing Records, validation protocols and reports) to secure compliance with GMP requirements. The right candidate is a strong team player and comfortable working across teams, R&D, Production, QC and QA.



Tasks and responsibilities

• Facilitate changes to SOPs, policies, training materials, and other documents as needed
• Be proactive in identifying and communicating GXP weaknesses and knowledge gaps
• Promote and raise the importance of Quality Management within the organization
• Manage corrective and preventive action reports and wider QMS activities
• Provide support for change control, validation activities, deviation investigations, Materials Review and release, as needed.
• Provides the required support during customer audits and regulatory inspections.
• Contribute to the supplier management process, as needed.
• Contribute to planning, preparation, performance, and reporting of GXP Audits for both internally performed activities and external contracted facilities providing key services to AZT.

Qualifications

• Master's degree in biotechnology, biology, biochemistry, chemistry, pharmacy or similar
• Minimum of 5 years of experience in the pharmaceutical or biomanufacturing industry
• Strong experience, extensive knowledge, and hands-on experiences of pharmaceutical manufacturing processes
• Experience with helping operations to prepare for FDA and /or EMA GMP inspection
• Strong communication skills with the ability to interact with all levels throughout the organization
• Ability to work methodically with good attention to detail
• Fluent in both written and spoken English.

Desirable Skills and Experience

• Experience in Chemistry Manufacturing and controls (CMC) for biologics
• Regulatory affair aspects of CMC/cGMP
• Experience in Submission of Drug Master file(s) to the FDA
• Experience in computerized systems validation

Location/Reporting

• The candidate will report to QA and Regulatory Manager
• Preferably Office based in Tromsø or Oslo, alternatively remote.
• 20-25% travel should be expected if the candidate is not based in Tromsø

We offer

This is a unique opportunity to join one of Norway's fastest growing biotechnology companies to develop new technology and products advancing life science research, diagnostics & bioprocessing. We offer an independent role in a space characterized by professional and personal growth. Flexible working hours, competitive salary and insurance.

We evaluate CV's and applications continuously, and if you have questions regarding the position please do not hesitate to contact Consultant Ingvild Ringen tlf: (+47) 988 04 308 or Branch Manager Thomas Lund tlf: (+47) 401 08 070.

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As an Equal Opportunities employer, we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.