ProPharma Group Sweden AB

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. ProPharma is supporting one of the leading Life-sciences groups globally with an interim/contract project support need based at their site in Sweden. This project requires subject matter expertise in GMP facility management within the sector which requires an immediate start. The project will run for at least 4 months and will offer full-time hours (1.0FTE) throughout the project duration. The role is mainly performed onsite just north of Solna and we are ideally looking to partner with independent consultants only. Essential Functions: Evaluate the current GMP facility activities and identify areas for improvement Lead and manage GMP facility improvement activities to ensure inspection readiness Review all SOP’s, work instructions etc. and update where necessary Provide technical support to a variety of tasks within GMP-critical system activities Work with other department heads to assess the current state of regulatory compliance and perform corrective changes to improve the facilities overall standard Act as the SME across the area and lead/support all ongoing projects where necessary Overall support to our client to ensure the successful completion of the project 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 GMP facility management within life-sciences at an SME level is a must Proven experience managing complex issues in GMP facility management and creating solutions would be highly preferred 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.*** Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on "English" at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.

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 a 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.*** Don’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests. To change the language, click on "English" at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language. ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (domain@propharmagroup.com). If you receive recruiting communications from anyone with a yahoo.com, gmail.com, live.com, propharmagroupjobs.com, or any other email account, it’s likely a fraud. Are you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.

Compliance and Quality Assurance Consultant - Product Quality Complaints - Permanent role hos ProPharma Group Sweden AB. Plats: 3 Locations. Publicerad: Posted 3 Days Ago. Referens: JR 10707. Ansök via Workday.