Sr. Associate Compliance (Global Distribution)
A Renowned Pharma company in Breda is looking for a Sr. Associate Compliance who is up for a new challenge, to Contribute continuously to improve the level of GDP compliance in Global Distribution Supply Chain.
• 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 Global Distribution.
• 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.
• Incidental travel might be required.
• 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, Dutch-preferable
• Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g., Track Wise, EDMQ, etc)
• Experience in audit / inspection support
• Technical writing skills
• 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
Start date: ASAP
Duration: 1 year (possibility of extension)
Please apply with CV. For further information, call Ernest Banor on +31 20 20 44 502 or by email at firstname.lastname@example.org