Freelance/Contract Principal Quality Assurance Consultant

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

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Here at ProPharma we are currently looking to partner with a highly experienced Quality Assurance Consultant (Lead level) to support a client for an urgent project. This contract/freelance role is to commence immediately; it offers full time hours throughout and will run for at least 3-4 months, if not longer. The client is ideally looking for independent consultants who can work largely onsite throughout in the Uppsala region.

Essential Functions

• 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

Necessary Skills And Abilities

• 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
• Must have extensive skills in problem solving, support corrective procedures and understanding key regulations to ensure compliance

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

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