Lead QA Consultant - Pharma/Biotech, Onsite Uppsala

ProPharma; Stockholms kommun; Hybrid; SEK 185,000 - 332,000; Full time

Job summary

ProPharma is seeking a highly experienced Quality Assurance Consultant (Lead level) to support an urgent project. This contract/freelance role begins immediately and offers full-time hours for 3–4 months, with on-site work largely in the Uppsala region.

The position involves reviewing QA activities, guiding remediation and CAPA, ensuring regulatory compliance, and supporting investigations. English is required (Swedish desirable); candidates should be able to work mainly onsite in Uppsala, with

Qualifications

• Must be educated to at least a BSc level or higher with a life-sciences discipline.
• Proven and extensive experience working within the Pharmaceutical or Biotechnology sector is a must.
• Extensive experience working in Quality Assurance across a range of aspects on a SME level.
• Proven experience managing complex issues in QA and creating solutions.
• Thorough experience to FDA regulations would be highly advantageous.
• Fluent in English (Swedish would also be desirable).
• Can work mainly office based in Uppsala throughout the project.

Responsibilities

• Review and support the development of key quality system activities in relation to compliance and global regulatory standards
• Can help support and guide our client for any quality remediation activities required to successfully complete the project
• Provide key support into Investigations and CAPA management
• Review all manufacturing activities from a QA perspective and ensure improvements where necessary are implemented
• Work on ensuring inspection readiness which includes compliance assessments and mock auditing
• Work closely with senior department heads and SME's to ensure the project is a success
• Overall support to our client as required

Skills

Quality Assurance

Regulatory knowledge

Investigations & CAPA

Inspection readiness

Problem solving

Fluent English

On-site in Uppsala

Education

BSc life sciences

Job description

ProPharma is seeking a highly experienced Quality Assurance Consultant (Lead level) to support an urgent project. This contract/freelance role begins immediately and offers full-time hours for 3–4 months, with on-site work largely in the Uppsala region.

The position involves reviewing QA activities, guiding remediation and CAPA, ensuring regulatory compliance, and supporting investigations. English is required (Swedish desirable); candidates should be able to work mainly onsite in Uppsala, with