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Bu iş sana uygun olmayabilir

Seçili özgeçmişindeki bilgilerle bu ilanın kriterlerleri sadece %30 uyumlu.

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Son iş deneyimin, geçmiş deneyimlerin ve toplam deneyimin uygunluk puanını etkileyen kriterler arasındadır.
Bu iş sana uygun olmayabilir

Seçili özgeçmişindeki bilgilerle bu ilanın kriterlerleri sadece %30 uyumlu.

Uygunluğunu nasıl hesapladık?
Mesleki Yeterlilikler
Şirketlerin ilanda belirlediği kriterlerle özgeçmişindeki bilgilerin ne kadar uyumlu olduğu içerik karşılaştırılmasıyla bulunur.
Bu iş sana uygun olmayabilir

Seçili özgeçmişindeki bilgilerle bu ilanın kriterlerleri sadece %30 uyumlu.

Uygunluğunu nasıl hesapladık?
Diğer Bilgiler

QUALIFICATIONS AND JOB DESCRIPTION

We are looking for a  "Temporary Quality Assurance Specialist" to our global company in biopharmaceutical sector.


Qualifications

  • 5 years+ of hands-on Quality Assurance experience in pharmaceutical/ biotech industry.
  • 2 years+ of hands-on experience in the production, quality assurance and quality control activities in one or multiple manufacturing sites
  •  Experience in product release and cold-chain distribution activities
  •  Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
  •  Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GxP and Pharmacovigilance required
  •  Ability to work globally in a matrix environment
  •  Ability to influence - management, peers and other colleagues without direct reporting lines
  •  Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  •  Experience in using SAP system.
  •  Experience in using computerized systems for Change Control, Deviation and CAPA management
  •  Advanced English level (both written and spoken)
  •  Leadership ability
  •  Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
  •  Good communication and interpersonal skills
  •  Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
  •  Ability to freely travel up to 30% (domestic and international)


Responsibilities:

  • Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to global quality and compliance systems, and associated procedures and standards.
  • Ensure the Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GxP and PV guidelines.
  • Provide internal auditing resource to assess compliance on a regular basis.
  • Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GxP/PV audits.
  • Provide Quality competence to the designated Affiliate and lead local/regional Quality activities
  • Quality Systems support contact within specific designated country
  • Could act as SME/Super user for key systems as part of the QMS
  • Create/revise procedural documentation
  • In collaboration with the Sr, Manager Country Quality, weigh and communicate quality and compliance risks as appropriate
  • Could act as Quality liaison between the local operational groups and Corporate Quality for GDP/GxP/PV functions and activities.
  • Together with Sr, Manager Country Quality, partner with local, regional and global operational groups to foster a proactive approach to compliance.
  • Interactions with regulatory health authorities, in alignment with Sr. Manager Country Quality, in case of potential falsification, diversion, counterfeit, theft, etc when needed.
  • Approve and maintain quality agreements with vendors relating to distribution and/or transportation of medicinal products.
  • Ensuring that a quality management system is implemented and maintained;
  • Focusing on the management of authorised activities and the accuracy and quality of records;
  • Ensuring that relevant customer complaints are dealt with effectively;
  • Ensuring that suppliers and customers are approved;
  • Ensuring that self-inspections are performed at appropriate regular intervals following a
  • prearranged programme and necessary corrective measures are put in place;
  • Keeping appropriate records of any delegated duties;

Randstad is an authorized agency of İskur with the licence date number : 17.10.2006 - 191

PREFERRED CANDIDATE

POSITION INFORMATION

Firma Sektörü:

İnsan Kaynakları Danışmanlığı

Çalışma Şekli:

Haftaiçi 09.00 - 18.00

Sosyal / Yan Haklar:

Özel Sağlık Sigortası

Çalışan Sayısı:

150-199