Senior associate Compliance (Global Distribution) |… | Undutchables

Senior associate Compliance (Global Distribution) | English C2

Breda, reference 2021-01860

Job description

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.
· Ability to apply risk-based approach, making decisions and escalating issues appropriately
· Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain.

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, Dutch-preferable
· Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc)
· 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


Working conditions

The company offers a challenging work environment with excellent career development programs. You have the opportunity to grow within the company and to fully develop your skills and competences.

Salary from: €2929,-
Salary to: €3460,-

Work location

Breda

Company description

Our client is an international market leader in the pharmaceutical industry – focused on transforming science and biotechnology into therapies that have the power to restore health or save lives. The patients are the main priority at all times. This USA founded organization holds a large site in Breda, where produced medicines are labeled, stored and shipped worldwide, to more than 75 countries. The staff in Breda works on supply chain processes, engineering, clinical research, marketing and sales on a daily basis. The company culture is dynamic and fast paced, with a strong international character.

Good to know

If you are interested in this vacancy, you can apply by clicking on the button above. Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission.We will invite you for an extensive interview, as soon as any potential job opportunities arise. We will advise you on issues regarding employment in the Netherlands. Then, if possible, we will introduce you to a prospective company and provide support during the selection procedure.

Recruiter contact

Roozs Abbas, Undutchables Eindhoven
roozs.abbas@undutchables.nl
+31 0634154231
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Want to apply?

Recruiter contact

Roozs Abbas
Undutchables Eindhoven
E: roozs.abbas@undutchables.nl
T: +31 0634154231

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