Scientist – Supplier Quality Management

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About the Role

As part of the Supplier Quality Management team, you’ll be responsible for executing the company’s supplier quality program and supporting a site manufacturing clinical and commercial drug substance. You’ll perform supplier evaluations, lead supplier audits, and support the site as a subject matter expert during audits and inspections. This role requires attention to detail, organization, and comfort interacting cross-functionally with internal and external partners.

About the team Quality Systems

Quality Systems is an important part of the Quality organization. You will be joining a diverse team of eleven highly qualified colleagues, all with several years of experience within quality assurance.

The Quality Systems team is responsible for maintenance and development of our quality systems for deviation, CAPA, change management, training management, and document control. We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers, as well.

Responsibilities

  • Execute the ACG Biologics Approved Supplier Program for the site.
  • Help develop the annual audit schedule.
  • Schedule and perform audits with suppliers (including contract laboratories).
  • Manage timely performance and closure of outsourced audit (i.e. audits conducted via consultants and other internal qualified resources).
  • Manage supplier CAPA follow-up (as part of management of the audit response).
  • Facilitating initial and lifecycle supplier qualification assessments.
  • Manage the site’s Approved Supplier List.
  • Act as supplier point-of-contact for quality-related topics.
  • Optimize the Supplier Quality program through management of or participation in continuous improvement projects.
  • Support customer audits and regulatory inspections as a Subject Matter Expert for Supplier Quality.

Candidate Profile

  • Masters Degree or PhD in pharmacy, biochemistry, or related life sciences field.
  • Minimum five years prior working experience in a Biotech/Pharmaceutical production environment, preferably with focus on supplier quality.
  • Strong knowledge of GMP guidelines, as well as international regulations, pertaining to the production of biopharmaceutical products (including, but not limited to 21 CFR Parts 11, 210, 211, 600, and 610; EU GMP Parts I, II, and III, and relevant ICH guidelines).
  • Proven technical writing skills.
  • Proven ability to perform supplier audits.
  • Skill in verbal communications. Ability to respond to complex inquiries from customers, co-workers, and supervisors regarding products and processes.
  • Strong knowledge of Quality Assurance concepts related to supplier management activities.
  • Skilled in time and priority management. Must be able to work under general direction to complete work tasks.
  • Demonstrated ability to work collaboratively to accomplish deadlines and objectives.

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.

Application
Submit your application as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

Want to keep posted about our growth and to learn more about our company?
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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 3.2.2022, 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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