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 d.finikova@panda-int.com 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 d.finikova@panda-int.com or call +31202044502 for more info.