Join a dynamic team where you'll play a key role in maintaining product quality and authenticity within the EU Regional Supply Chain network. Manage vital records, lead root cause analysis sessions, and support audits and inspections. Occasional travel might add excitement to your routine. Be the Subject Matter Expert in document management control and support product recall exercises. Enhance your expertise while enjoying incidental travel opportunities. Find out why this job might be the perfect match for your skills.

Over het bedrijf

Panda International

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Accountabilities

Embed the principles of Good Distribution Practices guideline (2013/C 343/01) in the EU Regional Supply Chain network, to ensure that product quality is maintained.
Embed the principles of the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the authenticity of Amgen product is maintained.

Responsibilities

Own and manage temperature assessment records (TEs).
Own and manage minor and major deviation records and lead root cause analysis sessions.
Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
Manage missing product notifications, including leading Event Review Team meetings if applicable.
Support audits and inspections involving EU supply chain, including audits and inspections at the affiliate level.
Support activities for product recall or annual mock recall exercises.
Incidental travel might be required.
Ensure up to date Smartsheet for minor, major, temperature excursions and missing products.
SME for document management control

Qualifications

Minimum Requirements
Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
Fluency in English and Dutch (preferable)
Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, Veeva, etc)

Preferred Requirements

Experience in audit / inspection support.
Technical writing skills

Interested? Send your CV to Daria at via de button "Solliciteer nu" op deze pagina. or call +31202044502 for more info.Accountabilities

Embed the principles of Good Distribution Practices guideline (2013/C 343/01) in the EU Regional Supply Chain network, to ensure that product quality is maintained.
Embed the principles of the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the authenticity of Amgen product is maintained.

Responsibilities

Own and manage temperature assessment records (TEs).
Own and manage minor and major deviation records and lead root cause analysis sessions.
Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
Manage missing product notifications, including leading Event Review Team meetings if applicable.
Support audits and inspections involving EU supply chain, including audits and inspections at the affiliate level.
Support activities for product recall or annual mock recall exercises.
Incidental travel might be required.
Ensure up to date Smartsheet for minor, major, temperature excursions and missing products.
SME for document management control

Qualifications

Minimum Requirements
Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
Fluency in English and Dutch (preferable)
Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, Veeva, etc)

Preferred Requirements

Experience in audit / inspection support.
Technical writing skills

Interested? Send your CV to Daria at via de button "Solliciteer nu" op deze pagina. or call +31202044502 for more info.

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