Quality Assurance Specialist

4 weeks ago

Copenhagen, Copenhagen, Denmark ProductLife Group Full time

ProductLife Group is seeking a Quality Assurance Specialist to support our customers in validation and compliance work within the pharmaceutical, biotechnology, and medical device industries.

The ideal candidate will have a bachelor's degree or higher and a minimum of 3-5 years of experience in the pharmaceutical, biotechnology, or medical device industries, as well as experience with test and validation.

The Quality Assurance Specialist will be responsible for validating computer systems, identifying and mitigating risks, preparing and executing validation protocols and reports, and providing IT support and assessment for quality deviations.

The successful candidate will have excellent English communication skills, good organizational and planning skills, and the ability to work collaboratively and as part of a team.

The position presents opportunities for growth, with greater responsibility over time.

The job requires knowledge and experience from projects that use the V-Model and GxP, with system validations spanning from pure IT to laboratory equipment and pharmaceutical production equipment.

The Quality Assurance Specialist will work under the guidance of a more experienced Compliance Manager and will be expected to coordinate, quality control, reports, and reviews.

The position is expected to be executed in accordance with internal and international guidance such as GAMP.

Key Job Functions: Coordination, Quality Control, Reports, and Reviews

Responsibilities:

  • Validate Computer Systems/Software Validation Procedures to ensure current regulatory compliance is met
  • Identify and mitigate risks
  • Prepare and execute validation protocols and reports
  • Provide IT support and assessment for relevant quality deviations
  • Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance
  • Author SOPs and Work Instructions compliance of IT systems
  • Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle

Background and Experience:

  • A bachelor's degree or higher
  • A minimum of 3-5 years of experience within the Pharmaceutical, Biotech or Medical Device Industries, as well as experience with test and validation
  • An attentive and detail-oriented approach, as well as the ability to independently resolve a variety of issues without close supervision
  • Good organizational and planning skills
  • The ability to work collaboratively and as part of a team
  • Excellent English communication skills (verbal, written, and interpersonal)

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