QA Principal Scientist with IT flair, QA Facility & Equipment

agcbio; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

AGC Biologics in Søborg seeks a QA Principal Scientist with IT flair to lead QA for Facility & Equipment and support IT/OT compliance. You will collaborate across IT, Engineering and Project Management, coaching colleagues and stakeholders while driving quality throughout GMP manufacturing.

The role emphasizes QA oversight, deviations, CAPA and Change Control, with a focus on validation, data integrity, and continuous improvement in a dynamic, global CDMO setting.

Qualifications

• Masters in Pharmacy or related field.
• 8+ years in regulated manufacturing environments.
• Experience in CDMO environment and QA oversight.

Responsibilities

• Review and approve SOPs and qualification documents (Qualification/validation protocol and report, URS, VPL, RTM, TEQ, CIL).
• Provide QA support on Deviations (DEV), CAPAs and Change Requests (CRs).
• Oversee IT Systems, Automation and Data Integrity to ensure GMP compliance.
• Lead improvement initiatives to increase efficiency of Quality processes.
• Review and approve system and equipment related quality documentation.
• Handle QA activities for facilities, utilities, equipment and computerized systems.
• Support Computerized Systems Validation (CSV) and trend analysis for quality activities.

Skills

QA

IT validation

GMP compliance

CAPA

Change control

Document review

CSV

BI dashboards

Education

Master's degree in Pharmacy

Job description

Are you passionate about QA and IT, and do you have high quality mindset? Now is your chance to join a very special role at AGC Biologics in Søborg as a QA Principal Scientist with IT flair, QA Facility & Equipment! Here you can utilize your QA background and help building a strong collaboration with key stakeholders in IT, Engineering and Project Management. As a Principal Scientist, you also get the chance to be supporting and coaching great colleagues and stakeholders across our business. We are looking forward to hearing from you!

You will be welcomed by a team of dedicated QA colleagues!

QA Facility & Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within QA. The main responsibility of the QA Facility & Equipment team is the quality assurance of Facility, Utility, Equipment and IT assets. In addition to our team, the QA department consists of the QA for QC team, QA Operations, Quality Systems, and QA Material Management teams.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim to constantly ensure that our GMP assets follow current standards for GMP production, i.e., EU GMP, 21 CFR, and ICH guidelines.

The QA department fosters open communication with a focus on a high level of professionalism. We are open-minded and highly supportive of our colleagues in the rest of AGC Biologics, as well as our stakeholders.

"We are looking very much forward to welcoming you to our great QA Facility & Equipment team! Your new colleagues are characterized by being positive and proactive, and together we are committed to meeting deadlines through our friendly collaboration with the business." - Sanaz Torab, Senior Manager of the team

Your skills in QA and flair for IT could be the perfect match for this role!

As a Principal Scientist in QA IT, you will be involved in various daily tasks in a dynamic and challenging environment. Your main responsibility will be to support our validation team and IT/OT team, which includes:

• Partner with other Departments/Groups/site for corrections and problem solving and best practices and alignment
• Review and approve SOP and Qualification Documents (Qualification/validation protocol and report, URS, VPL, RTM, TEQ, CIL etc.)
• Provides QA support on complex Deviations (DEV), CAPAs, and Change Requests (CRs).
• Responsible for overseeing IT Systems, Automation, and Data Integrity to ensure compliance with GMP.
• Lead improvement initiatives aimed to add efficiency to the Quality processes.
• Review and approve system and equipment related quality documentation
• Overall quality assurance activities related to the manufacturing facilities, utilities, equipment and computerized systems.
• Asset Management Related Tasks
• Support Computerized Systems Validation (CSV)
• Engage in the compilation and analysis of Trend Reports for quality activities related to Facility, Utilities, and equipment to identify improvement opportunities and driving associated initiatives.

Do you bring solid experience with QA and IT validation? To become our next Principal Scientist in QA, we are looking for someone with a relevant Masters degree in Pharmacy, Biotechnology, Biology, Engineering, IT etc. followed by 8+ years in regulated manufacturing environments, ensuring knowledge of GMP requirements. It is an advantage if you bring experience or an understanding of our CDMO environment. Your solid QA background makes you proficient in QA oversight, deviation handling, CAPA and Change Control and reviewing and evaluating qualification documentation.

To succeed in a role which combines QA and IT, we imagine that you have built knowledge in Computer Systems Validation with a strong interest in digitalization and continuous improvement. The core of this position is to be able to support IT/OT compliance to ensure compliance with regulatory requirements. It is a great advantage if you are familiar working with BI and dashboards, since we use these for reporting and presentation purposes.

As a colleague, you thrive in a dynamic and challenging environments. We are looking for someone who demonstrates problem-solving skills, reliability in meeting commitments, and provides exceptional stakeholder experiences. You must be self-motivated with a pragmatic attitude towards daily tasks, ensuring high quality without compromise. Our company language is English, so proefssional fluency is a requirement.

We are looking forward to hearing from you!

Who We Are AGC Biologics is a global Contract Development and Manufacturing Organization with a strong