Sr Associate Supply Chain Compliance Breda - Hybrid
40 hours per week
1 year contract to start with

Principle objectives of the position:

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 (CTETS).
• 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, CTETS 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

Competencies

• Effective communication skills at multiple levels, areas, and countries
• Ability to apply risk-based approach, making decisions and escalating issues appropriately.
• Analytical and evidence-based approach to problems.
• Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
• Pro-active in proposing solutions and driving tasks to completion.
• Works autonomously, respecting deadlines
• Works with a high degree of discipline and attention to detail