*QA Scientist, Facility and Equipment

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Could you see yourself being part of building a success story together with an ambitious team?

We are looking for QA Employees to assist with quality assurance of qualification/validation activities related to Equipment and Facility for phase I-III clinical trials and commercial manufacturing. Due to new projects and increasing activities the QA Facilities and Equipment team is expanding.

About the department

You will be a member of the QA department consisting of more than 50 colleagues with main responsibility for the areas: Manufacturing, Raw Materials, QC and Facility and Equipment.

QA Facilities and Equipment team consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance.

The main responsibility of the QA Facilities and 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.

The team handles review and approval of quality documentation e.g. qualifications of equipment, IQ, OQ, PQ related to facility equipment, Environmental Monitoring, Cleaning Validation, Deviation handling, Approval of CAPA and Change Requests

The job

This is an excellent opportunity for someone truly interested in making a difference on current operations as well as prepare us for the future.

We are looking for a Scientist who can, support our new facility project and assist with quality assurance of qualification/validation activities related to Equipment and Facility for phase I-III clinical trials and commercial manufacturing.

To succeed in the job, you have several years of experience within Quality Assurance. You naturally create a positive and inspiring environment around you. You will take ownership securing timely deliveries, support audit and securing timely audit response and timely and accurate reports to KPI’s.

As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. qualifications of equipment, IQ, OQ, PQ related to facility equipment, Environmental Monitoring, Cleaning Validation, Deviation handling, Approval of CAPA and Change Requests

Qualifications

You have experience with Quality Assurance of API manufacturing. Ideally, you have +3 years knowledge in several of the following areas:

  • Change Control, CAPA and Deviation handling including root cause investigations.
  • QA approval of qualification documents for:
    • Facility, Utility and Equipment
    • Computerized systems in cGMP manufacturing areas.
    • Computerized systems in cGMP QC Laboratory areas.
    • Environmental Monitoring in general

  • Knowledge and worked with CFR 21 Part 11 and EUDRALEX Annex 11
  • Communication in both written and spoken English is fluent.

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.

Application

We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible.

When the right candidate is in place, then the ad will close.

For further information regarding the position, please do not hesitate to contact Troels Risgaard Manager, QA Facility & Equipment +45 6160 3050

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.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 14.6.2022, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • København
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