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Sr. Associate Compliance / Technical Writer / Temporary (8 months) / GMP & GDP

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The company

Our client is a professional organisation, based in Noord-Brabant Netherlands. Our client is one of the top 10 bio- pharmaceutical companies, based in Noord-Brabant Netherlands. This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission 'to serve patients'.

Our client is a multi- cultural company that is looking for an Sr Associate Compliance (Technical Writer).

Curious what you are going to do?

Role description

The principle objectives of the position are 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. In addition you are responsible to 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.


Your responsibilities are:

- 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


Your requirements are:

- Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance. Or 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

Other information

For this position we are looking for someone who is pro-active in proposing solutions and driving tasks to completion and works with a high degree of discipline and attention to detail.

Is this something you can do and are you excited to work for a international pharmaceutical company? 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.

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SIRE Life Sciences®

Ref. number: 47370
Listed by: SIRE Life Sciences®
Listed on: 12-04-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 0 - 2 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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