Sr. QA Professional, Hillerød, Denmark
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Hillerød
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:
The skills required for this role include:
Qualifications
Application
Please upload your CV and cover letter in English as soon as possible as we screen applications on an ongoing basis:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Sr-QA-Professional_JR1428
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
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:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Sr-QA-Professional_JR1428
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 9.5.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Softwareudvikler
- Hillerød
- Mandag den 04. juli 2022
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