Freelance Qualified Person

ProPharma Group

Datum: 1 week geleden
Stad: Leiden, Zuid-Holland
Contract type: Voltijd
ProPharma Group
For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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 At present we are currently supporting a life-sciences client in Poland as their require support gaining their MIA license and help with Batch releases and compliance. This organisation specialises in the import and distribution of Medicinal Cannabis products globally and we are now looking for a “Qualified Person” ideally based in Poland (or in another EU country who speaks Polish) to support the project. This project will commence on the 1st March 2024; it requires 2 day a week support for at least 6-9 months and can be performed on a Hybrid basis with onsite presence in Poland Responsibilities include
  • Support and guidance to help achieve their MIA license
  • Support PAI Readiness
  • Participate and advise on Mock audit support
  • Batch release support once licenses have been attained
  • Help GMP certification
  • Overall support in QA where necessary
  • A University degree in Science/Engineering is required ideally to a MSc level
  • Must have demonstrated experience working as a QP in the EU (ideally in Poland)
  • Fluent in Polish and English is a must
  • Previous experience working with Medicinal Cannabis products would be highly desirable
  • Can perform the contractual requirements as demonstrated in the Job spec
  • Can travel to Poland or already residing in the country
  • Strong stakeholder management skills
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 ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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