Are you our new Quality System Engineer?

If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you.

You will work under the direction and supervision of the Halden Quality System Manager and support the document control and pre-printed batch material activities for the site. You will work with document change orders, related document control activities and support production directly by preparing and delivering pre-printed batch record materials. As our Quality System Engineer you will support Change Control and Document Control processes driving improvement throughout of the facility.

You will be a key resource in identifying and implementing best practices for change management, problem solving, and driving customer satisfaction. This position is hands-on in a fast-paced environment which interacts with multiple functions (QC, Production, Supply Chain, Engineering, Regulatory Affairs, etc) and other internal sites to resolve quality issues.

Main responsibilities

• Support and process document change requests within Q-Pulse
• Execute preparation of the daily pre-printed batch materials and deliver them to production
• Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system / GMP.
• Review document changes for accuracy and compliance with the change process.
• Work with peers within Halden and across Fresenius Kabi sites to improve and harmonize change management processes.
• Collaborate with internal customers to ensure quality standards are in place and compliant.
• Support change management activities to ensure process changes are managed and approved effectively.
• Become a qualified internal auditor and conduct internal audits
• Support all external audits by taking on roles assigned by their manager
• Support all improvement activities and react quickly to quality issues in manufacturing leading events to closure.
• Lean, understand, model, and champion current Good Manufacturing Practices behaviors within the facility.
• Provide support and input to the Q-KPI reporting tool for the site.
• Support and communicate with the site at the Quality Circle meetings.
• Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies
• Take on additional responsibilities as defined by the site QA Director.

Expectation of achievement

• Learn and grow within the quality assurance team taking on more responsibility.
• Provide consistent and timely support to the document control process.
• Ensure all pre-printed materials are deliver to manufacturing on time and with no quality issues.
• Quality issues are evaluated and reported in a timely manner to management when a field action or field alert might be required.
• Communication and cooperation with customers, authorities, notified body and suppliers is professional, and any requests are responded to in a timely manner.
• Timely support to projects according to agreed timelines
• KPIs are within defined limits and action is taken when expectations are not met.

REQUIREMENTS:

Education:

• Qualified individual should have a Bachelors Degree in Science in: Chemistry, Biology, Pharmacy, Engineering, Business, Mathematics, or technical field with emphasis on statistical and problem solving skills. Advanced degree preferred.

Experience: 

• Solid leadership, facilitation, and communication skills
• Understanding of problem solving or continuous improvement methodologies
• Awareness of ISO Quality Management Systems
• Excellent communication and interpersonal skills
• Ability to work independently across multiple organizations
• Good report writing and reviewing skills

Desired Qualifications:

• Working Experience with EU or FDA cGMPs
• 21 CFR part 211 or Part 820, ICH Q7, EU GMPs, or ISO13485 preferred
• AS9100 or TS16969 Quality Systems will also be considered
• Experience working in a Quality Control Laboratory
• Experience in the pharmaceutical or medical device manufacturing facility
• Good communications skills in Norwegian and English
• Exposure to process and/or software validation methods
• Operational Excellence/Six Sigma/Lean training or certifications
• Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
• Experience using Sparta Trackwise and/or SAP.

Personal characteristics

• Positive mind-set and an including attitude
• Ability to build good relationships
• Ability to work in a structured, systematic and dynamic environment
• Good communication- and cooperation skills
• Proactive and goal oriented
• Organized and quality oriented
• Ability to make decisions

For more information about the position, please contact QA Director Wayne Aaron Snyder (Aaron.Snyder(a)fresenius-kabi.com)

Søknadsfrist 31. Juli 2021