Validation Consultant
- Randstad
- 4000.00 - 6000.00
- 32-40 hours
- Bachelor degree
Client
Our client is a respected partner for life sciences companies.
Client
Our client is a respected partner for life sciences companies. Providing knowledge and expertise in phases ranging from drug development to commercial manufacturing. One of their expertises is the engineering, commissioning and qualification in pharmaceutical projects. Currently they are looking for a Validation Consultant to strenghten their team of Consultants.
Requirements
- Completed degree programme at Higher Professional Education (HBO) in engineering biotechnology, chemical technology, biochemistry, mechanical or similar;
- At least 3 years relevant work experience in the (bio)pharmaceutical industry;
- Preferably 2-3 years’ related work experience in projects or on project basis;
- Knowledge of pharmaceutical production plus equipment and the cGMP/EU/FDA requirements including latest developments relating to commissioning, qualification or validation;
- Knowledge about preparing, reading, checking and improving technical specifications (URS, functional specifications (FS), detailed technical specifications, technical drawings, P&IDs and PFDs);
- Experience in writing VMP, URS, DQIQOQPQ's and reports;
- Experience in preparing and supporting Risk Assessment and Design Reviews;
- Good communication skills;
- Proficient in Dutch and English. Fluent Afrikaans is sufficient as wel;
- Flexibility because of possible variety of projects and locations.
What do you get?
- Pension entitlement as from day one
- Collective WGA / WIA insurance
- NBBU / ABU collective labor agreement
- 25 holidays days
- 8,33% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance
Duties
As a consultant, you can be positioned in various roles depending your field of expertise. They involve you in projects of varying sizes in the pharmaceutical industry, biotechnology, healthcare, food industry and related sectors. Projects may be national or international in character. As a Consultant, you are expected to be effective from day one. The demand for deliverables is high while they also need to be of high quality. This means you combine complexitity, quality, deadlines and stakeholders all together. In many cases, you will develop, implement, validate and evaluate projects independently. In addition, you will be responsible for implementing a new process, product, procedure or quality system, for example. Additionally you might perform a GAP analysis, risk assessment or audit and work on developing and presenting customised courses and training sessions.During projects, you will also advise our customers in various areas. You will give the customer several options and explain which one you would advise. However, if a customer takes a different decision, you accept it but are also willing to warn a customer if you feel that this choice entails risks. If you are not entirely sure about something, you can always consult experienced and expert colleagues.
TAGCLOUD
engineering#biotechnology
#chemicaltechnology
#biochemistry
#mechanical
#pharmaceutical
#cGMP
#EU
#FDA
#commissioning
#qualification
#validation;
#URS
#functionalspecifications
#FS
#P&ID
#PFD
#VMP
#DQ
#IQ
#OQ
#PQ
#reports
- Experience in preparing and supporting Risk Assessment and Design Reviews;
- Good communication skills;
- Proficient in Dutch and English. Fluent Afrikaans is sufficient as wel;
