Qualification/Validation Specialist for QA F&E

  • Job reference
    4252664239

The QA Facility & Equipment team is looking for a qualification/validation specialist and as a qualification/validation specialist, you will work with qualification of equipment, facilities, utilities and systems in manufacturing and QC.  

You will, in collaboration with our specialists be responsible for the overall strategy for validation and expert within validation and qualification requirements. You will be a key stakeholder for regulatory surveillance of qualification of equipment, facilities, utilities and systems. 

 

QA Facility & Equipment 
QA Facility and Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within qualification activities. Besides the QA Facility & Equipment team, the quality unit department consist of the teams Quality Systems and QA Operation.  

You must enjoy working with and find solutions with colleagues who has different background in engineering, production and laboratory teams.  

You must enjoy performing practical qualification work on the shopfloor but at the same time have a scientific approach in trouble shooting and qualification. You must be able to handle challenges in a busy environment with a positive mind set. 

You will be part of a team of specialist from QA, validation, process development, production, analytical development and QC. You will participate in strategic planning of validation activities, prepare SOPs, protocols and reports, and in general facilitate continual improvement of the systems. 

The main responsibility of the QA Facility & Equipment team is to ensure that our production facility and laboratories at all times are in accordance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines. 

Develop your GMP skills and build relations with highly skilled people from the industry 
You will cooperate closely with the other teams in QA and departments at AGC Biologics in CPH and with colleagues from our sister sites in US, Japan and Germany in order to ensure that all quality related activities are carried out LEAN, effectively and in compliance with cGMP. 

Through internal and external audits, you are exposed to a lot of different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers.  

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA team is characterized by a positive and proactive environment colleagues working together in committed and friendly collaboration. 
 

Uddannelsesniveau
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Your Profile

You have experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API. Our Quality System is compliant to ICH Q7 and relevant parts of FDA 21 CFR part 11, 210, 211, 600 and 610. You have a relevant background within pharmacy, biotechnology or similar. Ideally you have QA knowledge in several of the following areas: 

  • Production of biotechnological products and APIs from development to late stage clinical production and validation of process (PPQ). 
  • IQ, OQ, PQ related to equipment, facilities, utilities and systems 
  • Technical knowledge of productions equipment used in biotechnological production 
  • Deviation handling 
  • Approval of Change Requests 
  • Regulatory inspections e.g. EMA, FDA and customer audits (internal and external audits) 

It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. 

AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent. 

  

Sprog
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AGC Offers 

AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. 


How to apply
Interested? Upload CV, motivation letter, references and criminal record via the link on this page, and do it as soon as possible. AGC Biologiscs is partnering with Adecco on this recruitment, so if you have any questions about the position, you can contact our recruitment team: 

Lotus Mølgaard +45 3838 1124
Tasja Sejerup +45 3838 1135


About AGC Biologics 
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.  

AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.  

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

 

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Om AGC Biologics

Kontaktoplysninger
Recruitment Team
+45 3838 1124 / +45 3838 1135