10 months ago
My client, a Global pharmaceutical company are looking for a Lead Auditor (Team Lead) based in Mannheim area, Germany.
A great opportunity to join an expanding team with a great portfolio of products.
Lead Auditor (Team Lead)
Location: Lead Auditor (Team Lead)
Duration: 6+ months Contract (possibility to get extended or signing permanent)
- Manage the submission, maintenance, and controlled substance filings for all EU PCC applications, licenses, and registrations. Update/remove drug codes and or drug schedules from licenses as required.
- Apply for all required import/export narcotics licenses in the EU and elsewhere as required.
- Prepare and manage controlled substance quota submissions.
- Host regulatory controlled substance audits, follow-up of compliance and close out of audits
- Insure and audit 3PLs and transport companies for controlled substance regulation and procedure compliance.
- Coordinate and manage the updates of the narcotic site license
- Coordinate with the relevant Serialization team for both internal site and or CMO's
To be considered you need to have:
- Eligibility to work in the Netherlands
- 3+ years' experience in controlled substance compliance experience
- 3+ years' experience working in Pharmaceutical or Biologics
- 3+ years' experience in GMP and GDP
- Knowledge in global serialisation
- English and German fluent
Looking but this isn't the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to firstname.lastname@example.org
Or callDE: +49 (0) 69 94189255
for a confidential discussion about potential opportunities.
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Catalyst Life Sciences
CLS are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets.
- Pre-clinical Development & Safety
- Clinical Development
- Medical Affairs & Information
- Regulatory Affairs
- Pharmacovigilance/Drug Safety
- Quality & Validation
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I personally specialise in recruiting QA, RA and validation professionals for roles across DACH so please do get in touch should you be considering new roles or looking to fill ones at your current company!
GMP /GDP / audit / supplier / lead / pharmaceutical / biopharmaceutical /