Freelance Quality Assurance Consultant

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

This is a 3 months freelance project requiring a commitment of 3-4 days per week. The work can be performed in a hybrid model of onsite and remote.

It is expected that you are able and willing to dig into the details yet keeping an eye on the overall goal of the project. You are result and clients oriented and have adequate interpersonal skills. You feel comfortable working with deadlines in an often changing environment and see it as a challenge to solve issues in a pragmatic and proactive way. The work will be executed under supervision and coaching of the QA Manager.

Responsabilities will include:

• Deviations Management.
• Change Management.
• Perform risk assessments.
• Follow up on observations, correction plans and initiated CAPA’s to ensure timely closure.
• Writing and approving policies, procedures, and work instructions.
• Leading project-related quality records.

• Bachelor’s degree in life sciences (Biotechnology or related) or comparable level through experience.
• Minimum of 3 years working experience within a GMP- CMO environment.
• Hands on experience in pharmaceutical operations or a laboratory.
• Sound knowledge of European rules and regulations on GMP.
• At least 2 years of in-depth experience with pharmaceutical quality management systems and compliance projects.
• Preferably experience with Lean management and 6 Sigma methodology.
• Excellent technical writing skills.
• Fluency in English and Dutch.

All candidates must be legally eligible to work in The Netherlands.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***