Senior Quality Engineer

Werkgever CheckMark Labrecruitment
Plaats Regio Leiden
Provincie Zuid-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum dinsdag 10 oktober 2017
Sluitingsdatum dinsdag 7 november 2017

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Functieomschrijving

You put your knowledge of GMP manufacturing and engineering into practise by contributing to the quality management system to get this 'audit-ready'. For this purpose you validate processes, documentation and deal with CAPA's in a GMP environment

As Senior Quality Engineer you work closely with professionals throughout the organisation, covering all actions required to improve the quality managament systems in a GMP manufacturing environment. 

- You ensure GMP compliance of the quality management sytem (QMS) and make sure that systems and processes that are aligned with teh company's strategy and regulatory requirements mission effecting continuous quality improvement 
- In your role as senior Quality Engineer you support, consult and lead quality improvement projects throughout the life cycle of the products. This includes product design and development, manufacturing, purchasing and improvements
- For this purpose you review validation documentation, software validation and investigations. You identify gaps and solve these
- Moreover, you conduct/lead CAPA's and use statistical tools to analyze process/product/QMS data and to identify improvement opportunities
- This way, you ensure that operations are done in compliance with the guidelines of regulatory authorities (e.g. FDA) and help to make the QMS and operations audit ready

Profiel

Opleiding HBO
Ervaring Ervaren (3 - 8 jaar)
For the position of Senior Quality Engineer we are looking for an enthusiastic candidate with a relevant educational background who meets the following qualifications:

- An academic (MSc, PhD) degre in engineering or science. Experienced BSc-level candidates are also considered
- At least 5 years relevant experience of which 3+ years with pharmaceutical or medical device companies
- Knowledge of statistics, software and process validations, combined with (basic) knwoledge of computer systems
- You thrive when doing multidisciplinary work, solving complex issues and have strong communication and influencing skills
- Fluent in English. Dutch is considered a plus

Aanvullende informatie

- Secondment via CheckMark Labrecruitment for 10 months
- Fulltime position

Contact

Neem voor meer informatie contact op met Coen Smiers: 0182 590 218
Vacaturenummer: 5447

Bedrijfsprofiel

This company develops and manufactures pharmaceutical products

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