In-house Quality Assurance Specialist

13 hours ago


Solna Municipality, Sweden PharmaRelations ApS Full time
About the Role

We are seeking a highly experienced Quality Assurance consultant to join our dynamic in-house team in Sweden. As a key member of our team, you will be responsible for ensuring the quality and compliance of our services, with a focus on the validation of computerized systems in the Life Science industry.

Key Responsibilities:

  • Develop and implement quality assurance strategies to ensure compliance with regulatory guidelines.
  • Conduct audits and assessments to identify areas for improvement and implement corrective actions.
  • Collaborate with cross-functional teams to ensure quality and compliance throughout the organization.
  • Provide training and support to colleagues on quality assurance best practices.
  • Stay up-to-date with industry developments and regulatory changes to ensure our services remain compliant.

Requirements:

  • Minimum 5 years of experience in quality assurance within GMP, with experience in GDP being a plus.
  • Minimum 3 years of experience in quality assurance and/or validation of computerized systems (CSV) within Life Science.
  • Strong understanding of quality assurance practices and relevant regulatory guidelines.
  • Knowledge in 21 CFR part 11, Eudralex vol. 4 annex 11, and GAMP 5 is mandatory.
  • Excellent command of Swedish and English, both written and spoken.
  • Project management experience is a plus.

What We Offer:

As a member of our team, you will have the opportunity to work with a dynamic and forward-thinking organization that is passionate about delivering high-quality services. You will be part of a collaborative and supportive team that values innovation, creativity, and continuous learning. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application via the link below. We look forward to hearing from you



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