The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands. Our client is based in Breda. Here medicines are labelled, assembled, packed and distributed to various countries worldwide. At the Breda site, more than 500 people are working every day on the manufacturing and distribution process. They encourage their team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities in a growing and dynamic business environment.
They offer you a great opportunity to be part of their growing company, work on your own development whilst making sure their medicines find their way to the patients who need them. Our client is looking for a Sr Associate CSO (Compliance).
Role descriptionAs a Sr Associate CSO (Compliance) you 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. Also do you embed the principles of the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the authenticity of our clients'product is maintained.
You have authority and the ability to apply risk-based approach, making decisions and escalating issues appropriately. Also do you contribute to continuously improving the level of GDP compliance in the EU regional supply chain network.
Are you ready for the job?
ResponsibilitiesAs a Sr Associate CSO (Compliance) you are responsible for:
- 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.
RequirementsThe requirements to be successful is this job, are:
- 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)
- 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
Other informationFor this the Our client is looking for someone you can start as soon as possible. The project will take longer than six months with the possibility for an expand. So what are you waiting for apply!
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.