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Technical Writer/Compliance Specialist Supply Chain

  • Job type Contract
  • Salary competitive
  • Location Breda, North Brabant
  • Sector Quality Assurance

Currently we are looking for an individual ready to take up the challenges Technical Writer.
The purpose of this position is to 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. I would be happy to provide you with more information. s.kolks(at)realstaffing.com or call me on 020 522 1588. Please note candidate must be currently based in the Netherlands. #technicalwriting #compliance #quality


It will be a six (6) months contract to start with. The client is located in Breda.

Sr Associate CSO (Compliance) for 6 months
Accountabilities
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 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.

Qualifications
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

Competencies
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