Freelance/Contract Senior/Principal Consultant - Sterility Assurance SME

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. Position overview ProPharma is currently supporting a market leading Pharmaceutical group as they require immediate support from subject matter experts in a variety of disciplines. In this particular project, we are seeking the support of a Senior/Principal level consultant in Sterility assurance in life-sciences who can perform a full time project (or as close as) for at least four months with possible extensions. The role requires substantial site attendance in Uppsala and ideally we are looking to speak to local contractors in Sweden (or the region but open to candidates who are happy to travel and work on site from UK/EU) who work as independent consultants. Essential Functions: Provide key expertise and leadership for Sterility assurance and contamination control strategies Support and lead aseptic processing activities Lead and support sterility-related investigations, including deviations, OOS/OOT results etc. Review and assess key data and identify trends/areas of improvement requirement Review and approve contamination control documentation and risk assessments. Provide technical guidance on cleanroom operations, gowning qualification and aseptic behaviors. Support qualification and validation activities related to sterile manufacturing processes. Participate in quality risk management exercises relating to sterility assurance. Support regulatory inspections, client audits and internal audits as sterility SME. Review and contribute to SOPs, protocols and reports relating to sterile operations. Overall support to the 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 Can thoroughly demonstrate advanced experience in Sterility assurance within the Pharmaceutical or biotechnology sector 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.***