Medical Compliance Officer | English

2 weken geleden

Eindhoven, Nederland Undutchables Voltijd
We are looking for a Supply Chain professional to own and manage temperature excursions, minor and major deviations, CAPA’s and CAPA EV’s that are reported in the EMEA region and to assist in various We are looking for a Supply Chain professional to own and manage temperature excursions, minor and major deviations, CAPA’s and CAPA EV’s that are reported in the EMEA region and to assist in various projects with related to continuous improvements and GDP topics across the organization. Parties involved are the EMEA GD organization, EMEA Supply Chain, EU Hub, Quality organizations, IS organization and external vendors.The position will report into the Sr. Manager Supply Chain Compliance.
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 the product is maintained.
Responsibilities• Own and manage temperature excursion records.• 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.• Support activities for product recall or annual mock recall exercises.• Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis• Support activities related to GDP-process improvements • 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 (C1 level)• Strong word processing, database and spreadsheet application skills and digital tools

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