FUJIFILM: Sr. QA Professional
Are you seeking a new and exciting challenge in the Biopharmaceutical Industry?
Would you like the chance to develop professionally?
Then come join our multicultural team of dedicated and highly motivated QA professionals at Fujifilm Diosynth Biotechnologies Denmark.
We are seeking an experienced Sr. Quality Assurance individual for the exciting Drug Substance Manufacturing (DSM) Expansion project in Hillerød, Denmark.
As a Full Time Employee (FTE), you will be working within a multi-disciplined group of Engineers responsible for the successful delivery of the Fujifilm Diosynth Biotechnologies Denmark (FDBD) Expansion Project.
FUJIFILM Diosynth Biotechnologies is a trusted partner to prominent biotech developers and pharmaceutical companies. Customer trust, digitalization, best place to work and expansion of capacity and capabilities are cornerstones of the Fujifilm Diosynth Biotechnologies strategy in Denmark.
The DSM expansion project is currently one of the largest and exciting Projects in Europe.
About the QA department
The QA team is responsible for the QA oversight on the execution and maintenance of the CQV Master Plan ensuring compliance with current regulatory requirements, Good Manufacturing Practices (GMP) regulations, GAMP 5, corporate policies, site Standard Operating Procedures (SOP) and Qualification and Validation cGMP’s. Also responsible for providing hands on QA support, guidance and direction to all involved areas in the organization with respect to Commissioning, Qualification and Validation (CQV) activities. This position reports to the Project Quality Assurance Manager.
Our team promotes diversity, work life balance and trust. Our main goal is to create a good relationship and collaboration with our team members, stakeholders and partners to deliver a high-quality service. You will be part of a great and very competent team. We keep a high energy level and we help each other to achieve the project deadlines. We have a lot of fun in the team and do exciting activities together.
About the role
You will provide QA support to the FDBD CQV as well as the Engineering functions in the DSM Expansion project and be responsible for the following:
- Responsible for the review and approval of all the engineering & validation qualification documentation such as:
- User Requirements Specifications (URS’s)
- Quality Risk Assessments (QRA)
- Requirement Treatability Matrix (RTM)
- Design Qualification (DS)
- Vendor FAT Protocols
- Turn Over Package documentation (TOP)
- Hygienic Welding Documentation
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Support the initiation and closure of the direct impact equipment /systems change controls, CAPA and nonconformance
- Ensure alignment with the CQV and Engineering leaders on the project plans and approach with consideration given to ASTM E2500, towards testing for all Systems, from FAT-IOQ
- Support vendor assessments as needed for impact equipment suppliers
- Support the scope of all Equipment/System Validation Qualification efforts with consideration of ASTM-E2500 Risk Assessment Approach
The skills required for this role include:
- Analytical skills – will gather and interpret data, must be able to spot trends and notice outliers
- Organizational skills – needed to keep track of testing, results, documentation, and recommendations
- Excellent written communication – concise and accurate written documentation is essential. Also required to review internal and external guidance, and potentially write company SOPs
- Interpersonal skills – involved in the training of project staff on quality systems, also working closely with project staff to find and adjust errors in the processes
- Keen attention to detail – must be able to identify when processes do not comply with guidance and provide alternative suggestions. Must be able to read and interpret the details of external guidance and industry regulations
- Critical/logical thinking – must identify problems but also be able to help provide novel solutions to ensure efficiency and quality of the manufacturing process.
Qualifications
- Minimum of 5 to 7 years of experience implementing and supporting QA Commissioning, qualification and validation equipment scope and liaising with the CQV & Engineering teams on pharmaceutical Projects.
- Experience as SME on Quality and Compliance issues
- Working knowledge of ASTM E2500 / Leveraging Verification process
- Working knowledge of GAMP 5
- Available to support FAT protocol execution at vendor locations
Application
Please upload your CV and cover letter in English as soon as possible as we screen applications on an ongoing basis.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
