Tech Transfer Lead

BeerseIFarmaceutische industrie

Functieomschrijving Select Projects is looking for a new colleague to join our team as a Tech Transfer Lead in a pharmaceutical company in Beerse.

Your tasks will consist of:
  • Writes User Requirement Specifications (URS), System Requirement Specifications (SRS), Qualification Summary Reports (QSR) and/or Impact Assessments (IA) according to GMP guidelines
  • Writes system qualification documents such as DQ/QP/IQ/OQ/PQ protocols and reports, based on information from meeting notes, similar previous projects, other departments, etc
  • Writes area Validation Master Plans, containing an inventory of all existing systems and their qualification status
  • Writes periodic assessments (PSQR) of the overall quality of GMP critical systems and deciding upon the need for re-qualification
  • In preparation of tests
    • Compiles map with necessary documents to be filled in
    • Prepares draft report
    • Understands critical quality aspects impacted,
    • Understands tests thoroughly,
    • Reflects on optimal sequence of tests to be executed,
    • Makes detailed planning of qualification activities if needed,
    • Verifies test materials in test order if needed
  • Executes qualification protocols and tests independently according to the approved format. Maintains oversight of tests to be executed.
  • Identifies gaps in procedures, qualification files or existing systems and escalates issues to the lead when needed
  • Assists in preparing for internal and external inspections
  • Communicates directly with involved departments during preparation for and execution of qualification activities
  • Acts compliant with GMP requirements and with general safety guidelines
Profiel As a Tech Transfer Lead 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 qualification and validation
  • 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
Tech Transfer Lead Vacature informatie
102206
Biowetenschappen I Techniek - projecten
Project sourcing
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