Your Job:
We are looking for the next Global Lead Auditing
You ensures 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.
Ensure sufficient auditors are trained and qualified withing Prothya. Processes audit results in a report for the auditee, containing identified bottlenecks, risks and recommendations on measures to be taken.
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.
Ensures collaboration within the group of internal and external auditors. Has 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 chemistry, Biology, Pharmacy or related · Several years of experience in cGMP environment Certification as auditor Knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems is required. Experience in training of internal / external auditors
Our offer:
We offer you a fulltime position with the following employment conditions
· A market-rate salary
· A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
· A fulltime employment of 40 hours per week
· Flexible working hours after deliberation
· Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
· Good accessibility by public transport and we provide private parking;
· Sound pension provision.
More info
If you would like to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your resume and motivation via the apply button on this page. We aim to respond to you within a week.
