*Principal QA Scientist - IT Compliance

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

We are looking for a QA Principal Scientist with a strong interest in IT Compliance and maintaining Data Integrity in Good Manufacturing Practice settings.

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 Principal 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 IT related quality documents, including but not limited to change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, and qualification protocols and reports
  • Driving process improvement and compliance initiatives
  • Representing Quality in AGC project deliverables
  • Acting as a subject matter expert during client audits, as necessary
  • 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
  • Providing guidance and training to colleagues and stakeholders on compliance related matters

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 Master's degree or equivalent
  • Thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines
  • Significant experience with the qualification of GMP computerized systems (GAMP5)
  • Knowledge of Data Integrity principles, and related guidelines such as CFR21 Part 11 and EU GMP Annex 11
  • Prior biopharmaceutical experience is desirable
  • 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.


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 10.2.2023, 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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