Utløpt

QA Manager Compliance

Arbeidsgiver
Fresenius Kabi Norge AS
Stillingstittel
QA Manager Compliance
Frist
Frist utløpt
Varighet
Fast

We are looking for a QA Manager to develop and manage a new department within our Quality Assurance unit. The Compliance manager will report to the QA Director. We are looking for a motivated and dedicated person which will work with the team to develop and strengthen the Compliance for the site. The QA Compliance manager will be responsible for the quality compliance program at Fresenius Kabi AS, Halden. This includes management of the supplier program; management and execution of the self-inspection program; management, development and implementation of Quality on the shopfloor; management of the external auditing and inspection program and the legal compliance program at the site.


Main responsibilities

  • Responsible for management, development and oversight of the quality compliance team.
  • Maintain process for Legal Compliance in the site by monitoring regulations related to pharmaceutical industry (ICH, cGMP, pharmacopeia and national regulations), ISO-standards and corporate regulations
  • Communicates observations from self-inspections and ensures that relevant responsible persons implement appropriate CAPA to address the observations.
  • Responsible for the external audit/inspection program, including hosting and facilitating external audits/inspections.
  • Qualify as Lead auditor for internal and external audits
  • Participate and host external audits/inspection at the site
  • Support the site organization with training in the respective quality systems
  • External presentation and communication towards customers, authorities and corporate organization in topics related to quality assurance and compliance topics.

 

Requirements to education, experience and personal characteristics

  • Master degree in Chemistry, Biology or Pharmacy
  • 3-5 years’ experience in a Management position with personnel and budget responsibilities.
  • Documented 3-5 years’ experience in ISO/cGMP quality systems
  • Excellent ability and high interest in using, managing and developing IT-systems for Quality Assurance.
  • Excellent skills in writing and speaking Norwegian and English.
  • Experience from an international company with cooperation and communicating in different levels in the organization.
  • Personnel skills: Proactive, good in cooperation and communication, dedicated and able to motivate the team.

If you would like more information about the position, please contact QA Director Anne-Mette Horsrud Akre, tel: +47 69 21 11 00.

Om arbeidsgiveren

Fresenius Kabi Norge AS is a leader in Norway in its segment producing medicines, with revenues to numerous countries worldwide. The position is located in our growing production facility in Halden with over 660 employees. Fresenius Kabi is included in the German group Fresenius SE, with headquarters in Frankfurt. The group has currently more than 274 000 employees

Sektor
Privat
Sted
Svinesundsveien 80,
1788 Halden
Bransje
Farmasi og legemiddel,
Medisinsk utstyr og rekvisita
Stillingsfunksjon
Kvalitetssikring,
Ledelse

Nøkkelord

QA Manager, Compliance, quality compliance program, supplier program, legal compliance program

Rapporter annonse

FINN-kode
151083309
Sist endret
8. aug 2019 11:24

Spørsmål om stillingen

Kontaktperson
Anne-Mette Horsrud Akre
Stillingstittel
QA Director
Telefon
69 21 11 00
Følg firma
71 følger dette firmaet

Svinesundsveien 80, 1788 Halden

Stort kart Hybridkart Flyfoto

Rapporter annonse

FINN-kode
151083309
Sist endret
8. aug 2019 11:24