Qualification Engineer

BeerseIFarmaceutische industrie

Functieomschrijving Select Projects is looking for a new colleague to join our team as a Qualification Engineer in a pharmaceutical company in Beerse.

Your tasks will consist of:
  • Provides business support as technical owner (questions, technical issues, ...)
  • Makes detailed assessments for the projects, changes, modifications, good practices, corrections, remediations, break-downs, non-compliance issues, investigations, etc
  • Reviews and approves qualification test and documents written by qualification engineers or other testers (URS, SRS, IA, DQ, QP, IQ, OQ, discrepancies, PQ, QSR, VMP, PSQR, ...)
  • When packaging activities are leveraged for qualification purposes, reviews and approves the packaging line trial before execution and the documented line trial
  • Initiates and follows-up QI’s and corrections in Trackwise when needed for projects, changes, etc
  • Assists in preparing for and providing support during internal and external inspections, in maintaining the area Validation Master Plans, containing an inventory of all existing systems and their qualification status.
  • Assists in performing periodic assessments (PSQR) of the overall quality of GMP critical systems and deciding upon the need for re-qualification, in performing and reviews periodic assessments and in providing introductory qualification trainings
  • Supports and if needed, guides, qualification engineer in evaluation of project issues and changes towards impact on approach of qualification activities (f.e. deviations from protocol, scope changes)
  • Works together with the qualification engineer to make sure qualification activities are performed in a qualitative and timely manner (within reasonable expectations) and with the QA qualification team to get qualification files approved
  • Communicates with the involved departments regarding test planning, test materials, resources, etc
  • Maintains a current knowledge of international regulations, GMP guidelines and industry practices related to system (process equipment) qualification

Profiel As aQualification Engineer you have/are:
  • Master of science e.g., bioengineering, industrial sciences, civil engineering, chemistry, biochemistry, 
  • First relevant work experience within life sciences industry
  • Affinity with compliance and quality
  • Very good communication skills in English (both written and oral). Good knowledge of Dutch is a plus.
  • Good knowledge of MS Office
  • Analytical thinking
  • Proactive mindset
  • Independent
Organisatie- en afdelingomschrijving At Select Projects, the customer's experience with our employees is central. It is our consultants who ensure an optimal experience by delivering the highest quality. Your expertise is central to this and you can grow at Select Projects so that you become and give the best version of yourself. As a consultant, you bring knowledge and skills and you have the will to succeed. What is in return?

Select Projects offers interesting projects, opportunities for growth, autonomy, trust, training and professional colleagues you can learn from. This allows you to work on your professional growth and personal development.

At Select Projects, you are not only part of the team at the client. You also form a team with your fellow consultants in the field. We have family values where we help each other and pay attention to each other. This allows you to become and give the best version of yourself. Working at Select Projects means that you work on your craftsmanship and are therefore the specialist in your field.

Aanbod Select Projects ensures that you will have a pleasant working environment with fun colleagues where team spirit is central. We organize after-works, personnel parties, sports events, team buildings, etc.

We offer you opportunities to develop yourself and to grow further. Together with you, we map out a training route tailored to your future plans and needs. At Select Projects, you can become and give the best version of yourself.

In addition, Select Projects offers you a permanent contract. You get an attractive salary package with the following benefits:
  • Possibility of a company car with fuel card
  • Meal & eco cheques
  • Expense allowance
  • Group & hospitalisation insurance
  • 12 ADV days on an annual basis
  • 13th-month pay
  • Single and double holiday pay
  • Bonus system: collective bonus and individual bonus
  • Possibility to participate in Flex Income Plan
Heb je nog vragen?
Sakina El Kasmioui Talent Acquisition Specialist +323 600 08 65
Qualification Engineer Vacature informatie
102210
Biowetenschappen I Techniek - projecten
Project sourcing
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