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 Pharmaceutical brand as we continue to support their Qualified Person activities throughout the EU. At present we are looking to partner with an independent Consultant who can help support their German operations on a remote basis. The project will offer on average 5-10 hours per month for general tasks over a 12 month period (2025) and would also require one week onsite for batch release activities during the year. There will also be a training/onboarding period and the role can be performed fully remotely from any location but ideally Germany if possible.
Responsibilities include
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Performing Batch release activities on a rolling basis
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SOP review
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Supporting the setup of the QMS
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Add input into the continuous improvement of the QMS
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Support internal audits
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Be named on the license as the official Qualified Person and act accordingly to the regulations
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Overall support to ensure the site is compliant and reaching its objectives
Qualifications
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University degree in Pharmacy or a relevant life-sciences discipline allowing you to be a Qualified Person
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Must be certified as a Qualified Person
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Proven experience working with Solid dosage products is a must (API)
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Fluent in German and English is a must
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Can perform the role to the job spec requirements
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Strong stakeholder 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.***
Top Skills
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
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