Description de fonction
At the moment, we're looking for a
Technical Writer for our team in the pharmaceutical sector. You'll support the C&Q team in providing documented evidence that used equipment and utilities are qualified and remain in a state of control to make sure that they comply to regulatory and business specifications. In this role you will be responsible for writing and executing qualification protocols, tests and reports.
As a
Technical Writer you will:
- Write User Requirement Specifications (URS) or System Requirement Specifications (SRS) and Impact Assesments (IA)
- Document the test results according to GMP and C&Q guidelines
- Write system qualification documents such as DQ,QP,IQ,OQ,pQ protocols and reports
- Assist the C&Q lead in preparing for internal and external inspections
- Identify gaps in procedures, qualification files or existing systems and alerting C&Q lead
- Make assessments for projects
- Execute qualification protocols and tests independently according to the approved format
- You act compliant with GMP requirements
- Attend meetings
- Escalate issues to C&Q lead when needed
- Support training to new team members when necessary
Profil- You have obtained a MASTER DEGREE
- You have at lest 3 years of experience in the pharmaceutical sector
- You communicate fluent in DUTCH and ENGLISH
- You have a good knowledge of GMP
Descriptif de l’organisation et du département
At
Select Projects, the customer's experience with our staff is key. It is our consultants who ensure an optimal experience by delivering the highest quality. Your professionalism is central to this and you can continue to grow at
Select Projects so that you become and give the best version of yourself. As a consultant, you bring knowledge and skill and have the will to succeed. What is in return?
Select Projects offers substantively interesting projects, growth opportunities, autonomy, trust, training courses and expert colleagues you can learn from. This allows you to work fully on your professional growth and personal development.
At
Select Projects, you are not only part of the team at the customer's site. You will 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 working on your craftsmanship and therefore being the specialist in your field.
Offre
Select Projects ensures that you end up in a
pleasant working environment with fun colleagues where team spirit is key. We organise after-works, staff parties, sports events, team building, etc.
We offer you opportunities to develop and evolve. Together with you, we map out a
training programme 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 of undetermined duration. You receive an
attractive salary package including the following
additional benefits:
- Possibility of a company car with fuel card
- Meal & eco vouchers
- Expense allowance
- Group & hospitalisation insurance
- 12 ADV-days on an annual base
- End-of-year bonus
- Single and double holiday pay
- Bonus system: collective bonus and individual bonus
- Possibility to participate in Flex Income Plan