Sr. Associate QA

1 dag geleden

Breda, Noord-Brabant, Nederland Hays Voltijd

Your new company

Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. The company focusses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, they have grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Your new role

  • You will be responsible for performing QA oversight for validation of equipment and packaging qualification.
  • Perform review and approval of equipment validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
  • Provide quality support for testing strategies and quality investigations.
  • Perform review and approval of master data on the electronic batch record platform (PASX)
  • Site and Regulatory requirements are met.
  • Provide quality support for testing strategies and quality investigations.
  • Manage ABR's device responsibilities and ensures alignment with GMP regulations.
  • Performs a final review of technical change controls, confirming assessments of different stakeholders are complete, and all tasks are correctly represented in the record.

What you'll need to succeed

  • An MBO or Bachelor's degree in Life Sciences or process technology related field, or the equivalent combination of education and/or experience.
  • 3 years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
  • Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.
  • Fluent in English.
  • Experience with pharmaceutical industry, deviations and Change Controls
  • Effective communication skills at multiple levels and areas (inside and outside of Quality).
  • Good attention to detail and excellent writing skills.
  • Good decision-making skills and ability to apply a risk-based approach.
  • Teamplayer, constructively working together towards solutions.

What you'll get in return

NOTE: This role is for 12 months duration. In this position, you will get a competitive salary and your travel expenses are covered. This role also offers a 13th month.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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