Are you our new QC Manager Validation, Qualification, Compliance?

If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you! In this role you will provide leadership and scientific expertise in analytical chemistry, analytical method validation and ensuring that the methods are in compliance with relevant legislations and guidelines.

Main responsibilities

• Lead method transfer, validation, verification and implementation into QC Laboratory
• Lead and perform qualifications of analytical instruments
• Create and maintain specification for raw materials, components and formulations. Ensure that all established specifications are in compliance with current pharmacopeias and GMP regulation
• Attend project team meetings as a QC representative and work closely with the project manager team to ensure on-time delivery
• Writing and approval of quality documents: SOPs, protocols, reports, specifications and method of analyses
• Monitoring and implementation of pharmacopeia and regulatory updates
• Serve organization as SME in analytical chemistry
• Follow up on deviation, incidents, CAPA and change control related to validation and specification topics
• Represent department during external audits

Key Requirerments

Education:

• Bachelor or Master’s degree in chemistry, pharmacy, biotechnology, engineering or similar.

Experience: 

• Advance experience in analytical chemistry and quality control in pharmaceutical industry
• Several years of experience with method validation and transfer, especially in different chromatography techniques (HPLC, GC, TLC) and titrations.
• Experience in qualification of analytical instruments.
• Good understanding of the laboratory software such as Empower or LIMS.
• Experience with updating quality documents according to newest regulation for pharma industry.
• Ability to apply cGMP regulations and international guidelines to all aspects of the positions.

Personal characteristics

• Positive mind-set and an including attitude.
• Good communication- and cooperation skills.
• Excellent planning, organizational and problem-solving skills.
• Ability to manage competing priorities and ensure on time deliveries of project responsibilities.
• Ability to establish and maintain effective working relationships with coworkers and managers.

For more information about the position, please contact QC Director Jan Magnar Volle (jan-magnar.volle(a)fresenius-kabi.com)

Søknadsfrist 20. august 2021