Would you like to be a part of AGC Biologics' growing success?

We are looking for a QA Scientist with a strong interest in qualification of GMP Facilities, Equipment and Computerized Systems.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time.

Position Overview:

As the QA Scientist, you will be a vital member of a highly motivated, multidisciplinary team. Your daily responsibilities will include:

Overseeing the Quality Assurance review and approval of all technical documents, including but not limited to:
- Change Controls
- Deviations
- CAPAs
- Risk assessments
- SOPs
- Validation Plans
- Requirements Specifications
- Qualification Protocols and Reports
Conducting GEMBA walks in GMP areas
Communicating with internal and external stakeholders to resolve and clarify any points of issue
Contributing to the creation of the Annual Product Quality Review (APQR), as needed

Your Profile:

It is crucial to possess a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality. Our working environment is dynamic and demanding, necessitating the capability to problem-solve, fulfill commitments, and provide a favorable experience for our clients.

Education and Experience:

The ideal candidate should possess the following qualifications

A science-based degree
Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site
Prior biopharmaceutical experience is desirable
Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
Experience with the qualification of GMP facilities, equipment, and computerized systems
Knowledge of Data Integrity principles
Strong decision-making skills and a proactive attitude
Excellent written and verbal communication skills
Ability to work efficiently in a fast-paced, matrix environment
Ability to meet deadlines and effectively manage multiple tasks
Flexibility to adapt to changing business needs and priorities.

At AGC, we serve international clients and English is our company language. As such, professional proficiency in both written and spoken English is a requirement.

About The Department:

You will be joining the Quality Assurance department, consisting of over 80 colleagues, with primary responsibilities in Manufacturing, Raw Materials, Quality Control, and Facilities and Equipment.

The Quality Assurance Facilities and Equipment team is comprised of highly qualified scientists with diverse professional backgrounds and several years of experience in the field of Quality Assurance.

The main objective of the team is to ensure that our production facilities and laboratories comply with current Good Manufacturing Practice (GMP) standards, including EU GMP, 21 CFR, and ICH guidelines at all times.

The team is mainly responsible for the review and approval of quality documentation, including equipment qualifications, IQ, OQ, PQ, environmental monitoring, cleaning validation, deviation handling, and approval of CAPA and change requests.

Applications:

We continuously assess incoming applications and schedule interviews accordingly. To ensure prompt consideration, please submit your application and resume promptly.

The advertisement will be closed once the ideal candidate has been identified.

For additional information regarding the position, feel free to reach out to Volker Jentzsch, Senior Manager of QA Facilities & Equipment, at +45 2294 3062.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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Pursuant to art. 13 of Regulation (EU) 2016/679 (hereafter "GDPR"), laying down provisions for the protection of persons and other subjects regarding the processing of personal data, we wish to inform you that the personal data you provide will be processed in compliance with the aforementioned legislation.

AGC Biologics Inc., together with its parent company, its subsidiaries and affiliates (collectively, “AGC Biologics Group”, “we”, “us” or “our”), recognize the importance of protecting your privacy. This Policy is designed to assist you in understanding how we collect, use, safeguard and disclose your personal information when using the “join our team” service. We also describe how you can contact us about our privacy practices.

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You are informed that your data is collected by the specific AGC Biologics Group company and processed in accordance with the applicable laws.

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By sending your curriculum vitae (CV), you are communicating your personal identification data concerning your training and work experience. Pursuant to articles 9 and 10 of the GDPR, you could give us data qualifying as "particular categories of personal data" (ie those data revealing "racial or ethnic origin, political opinions, religious or philosophical convictions, or union membership, data relating to the health or sexual life or sexual orientation of the person”). With reference to the processing of these particular categories of data, we inform you that, if not necessary for the purpose of completing the selection activity, it is preferable to avoid the inclusion in the CV of such sensitive data.

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The personal data you provide are necessary to evaluate your potential suitability for the purpose of a possible inclusion within our staff.

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The provision of personal data indicated as required is necessary. Therefore, any refusal to provide such data would make it impossible to manage the relationship with you and would then cause the impossibility of your possible inclusion in our staff.

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With respect to the activities and purposes stated above, personal data will be processed exclusively by employees and / or collaborators of the Data Controller, also through third parties appointed as Data Processors (e.gg. business consultants or external companies in charge of maintenance of the “join our team” service and related activities), in compliance with the provisions of the law also with regard to security measures to protect and safeguard the data provided.

The list of Data Processors can be requested to the Data Controller.

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The data collected will be kept for the time strictly necessary for their treatment and in any case no later than one year/six months, unless you authorize us to extend such period, following our written request.

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Your personal data may be transferred to, and processed in, countries other than the country in which you are resident. These countries may have data protection laws that are different to the laws of your country (and, in some cases, may not be as protective).

Specifically, our servers are or will be located in the European Economic Area or EEA or any other country that is compliant with the principles of the GDPR, and third party service providers and partners operate around the world. This means that when we collect your personal data we may process it in any of these countries.

However, we have taken appropriate safeguards to require that your Personal Data will remain protected in accordance with this Policy. These include implementing an intra-group data transfer agreement based on the European Commission's Standard Contractual Clauses (the "Intra-Group Data Transfer Umbrella Agreement") for transfers of Personal Data between our group companies, which require all group companies to protect Personal Data they process from the EEA in accordance with the GDPR.

We have implemented similar appropriate safeguards with our third party service providers and partners and further details can be provided upon request.

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Within the limits of the GDPR, you have the right to ask us, at any time, to access your personal data, to rectify or cancel them or to oppose their treatment, the limitation of processing and to obtain a structured format, in common use and readable by automatic device data concerning you.

Requests should be sent to the Data Controller using the address indicated in the position description.

In accordance with applicable law, you have, in any case, the right to lodge a complaint with the competent supervisory authority (Personal Data Protection Authority) if you consider that the processing of your personal data is contrary to the law in force.

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You may request more information in relation to the processing of your personal data at any time using the contact information.

Changes to this privacy policy

We reserve the right to make changes to this privacy policy at any time by giving publicity to users.

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QA Scientist Facilities and Equipment

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