Medical Compliance Officer | English

Breda, reference 2024-01658

Job description

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

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 (C1 level)• Strong word processing, database and spreadsheet application skills and digital tools

Working conditions

• 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.
• Hybrid position, once or twice per week on site in Breda.
• For this role, the company offers a competitive salary package.
• Reimbursement of travel expenses is dependable on travel distance.
• This a temporary role.

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.For this role, it is important that you currently reside in the Breda area.

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

Valeria Miozzi, Eindhoven
[email protected]
+31(0)6-34580376