Senior Quality Assurance Officer - Haarlem

Vacancy information

Publication date:January 08 2021
Employment type: Permanent
Sector: Pharmaceutical
Function Group: Quality/RA

Functiegroepen: Quality/RA

Organisatie

For an international pharmaceutical company in the Amsterdam area, we are currently looking for a Senior Quality Assurance Officer. The Quality Assurance department ensures that all the products are produced, processed, tested, packaged, stored, and distributed according to high-quality standards and the applicable rules and laws. By creating a close collaboration between the internal manufacturing facilities and external partners and suppliers, the team ensures a global manufacturing network committed to providing validated and reliable delivery to customers and patients around the world.

Within the quality release department, there is a sub-department called quality release specialties. The quality release specialties team consists of 20 employees and supports the entire site with regard to the quality assurance and quality release activities of various products and the introduction of new products to the market.

Functie

As a (Senior) Quality Assurance Officer, reporting to the Quality Manager, you are responsible for:

  • Supporting departments in implementing changes to guidelines (via Trackwise, Orion, and change control processes)
  • Contributing to a growing quality awareness within the business environment of our production location in Haarlem, propagating the quality system, and being a representative for quality within various systems
  • Participating in the introduction of new products. Within these projects, you are responsible for the quality aspects
  • Quality assurance for a number of products
  • Reviewing and approving artwork (GLAMS), components bill of materials, and bulk bill of materials
  • Preparing regulatory compliance activities, such as Registered Country Table management, QP statements, and analysis certificates
  • Assessing quality standards and setting up the correct software systems (GLIMS and SAP)
  • Material control review/approval in SAP
  • Preparation and review of Certificates of Analysis (both manual and within SAP)
  • If necessary, deviation management review and assessment of product quality complaints
  • Writing and maintaining relevant QMS procedures

Functie-eisen

The ideal candidate has the following skillset:

  • HBO / WO pharmaceutical, life sciences, process engineering, or chemical background, supplemented with 3 years of relevant work experience in the field of quality
  • You have experience as a Quality Assurance Officer, Quality Release Officer, or similar and you have experience with GMP
  • Experience with (setting up) SAP, LIMS, and Trackwise is an advantage
  • Experience with packaging technology is an advantage
  • Experience with registration of medicines is an advantage
  • Persuasiveness and result-oriented
  • Accurate, flexible, and independent
  • Good communication skills in both spoken and written Dutch and English

Aanbod

The organisation can offer you:

An International work environment with dedicated colleagues where you are given all the space to develop yourself and to show who you are.

You can also count on attractive terms of employment:

  • A competitive salary between 50k and 70k
  • 35.5 vacation days
  • 8% holiday allowance and 3% year-end bonus
  • Incentive plan
  • An excellent pension
  • Free use of the gym
  • Travel allowance
  • Different training modules

Sollicitatie

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Daniel Donker
Principal Consultant | Biotech & Pharma

+31(0)6-82564401
+31(0)23-7548660
d.donker@qtcrecruitment.com

Solliciteren
 

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