Your responsibilities:
You ensure that internal and external audits are adequately designed, carried out and managed, ensuring sufficient support for fellow auditors and SMEs. Is therefore involved in the execution of audits both independently and coordinatingly.
Assesses the auditee’s action plan for completeness, timeliness, accuracy and alignment with Prothya’s QMS, identifies bottlenecks with internal and external stakeholders and monitors the follow-up of measures to be taken. Translates annual departmental business objectives to the audit program.
a broad and in-depth understanding of existing and emerging regulatory GxP requirements within own field of expertise.
Decision maker with regards to GxP (e.g. decisions on batch dispositions).
Manages or gives advice on SOPs, GxP deviations and change control and follows mandatory GxP training and maintains an appropriate training record.
Has understanding of existing regulatory GxP requirements (within area of own expertise). Interacts cross functionally to ensure GxP compliance and writes SOPs.
Follows mandatory GxP training and maintains an appropriate training record. Writes GxP documentation such as deviations and change control records. Takes GxP requirements into account during preparation, execution and reporting of GxP activities.
Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
Takes GxP requirements into account during activities. Follows mandatory GxP training. Identifies and escalates GxP issues.
Your profile:
Bachelor’s degree in Life Sciences, Biology, Pharmacy or related
Several years of experience in cGMP environment
Certification as auditor or ability to get this certification
Knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems is required.
Flexibility to travel inside and outside the Netherlands
High level of English
Where you will work
Prothya Biosolutions is one of the few end-to-end pharmaceutical companies in the Netherlands. Our production process goes through all steps from raw material to filled and packaged end product. The production process meets the highest requirements as laid down in the GMP. Quality and safety are regularly checked by Dutch and international authorities.
What we offer
Full-time employment
8.33% end of year bonus and 8.33% holiday allowance
Flexible working hours in consultation
Personal training budget of €2,000 per 3 years
Contribution to travel expenses from the first kilometer
Good accessibility by public transport and private parking
Pension plan at Zorg & Welzijn
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