Associate Compliance

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.

The Company

This client based in Breda openend a new and urgent position for a Associate CSO (Compliance)

Role Description

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 the companies product is maintained.

Responsibilities

• Maintain the supply Chain Distribution manual
• Participate in Supply Chain Distribution Risk Management activities
• Own and manage temperature assessment records (CTETS)
• Own and manage class 1 and class 2 non-conformance 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.
• Author and Own documents (procedures, forms, manuals, training materials, etc) for the Customer Success department and the Compliance team.
• 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.
• Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis
• Incidental travel might be required.

Authority
Ability to apply risk-based approach, making decisions and escalating issues appropriately

Outputs
Contribute to continuously improving the level of GDP compliance in the EU regional supply chain network.

Requirements

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, 7+ 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, EDMQ, etc)

Preferred Requirements
• 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

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.