Freelance Responsible Person
vor 1 Woche
Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
**Job Description**:
We are currently looking for freelancer who is looking for a long term opportunity working as a Responsible Person for one of our key clients. In this challenging requirement, we require a freelancer who can offer 1.0 FTE; be available at least for 12 months (ideally longer) and have all the necessary skills to hit the ground running.
**Essential responsibilities include**:
- Act as Responsible Person (GDP), administrative batch release
- Dealing with all product complaint topics
- Assess the suitability of 3rd party suppliers and ensure compliance
- Traceability / stock reconciliation
- Return to stock management (reject / approval)
- Product recalls
- Alerts Management / communication NMVOs
- Repackaging operations
- Identify training needs linked to GDP and devise training procedures and modules to upskill key areas
- Host regulatory inspections when required
- Support change control, deviation management, CAPA‘s
- Ensure all documentation and records is in line with the clients SOP’s and necessary regulations
**Qualifications**:
- Educated to at least a BSc level or more within a life-science or related discipline
- Must be a proven RP with demonstrated exposure working within a life-sciences setting
- Previously named on an official license would be highly desirable
- Demonstrated experience working in Quality Assurance would be preferred
- Fluent in English and German
- Can offer 1.0 FTE (or very close) on a long-term basis as a Freelancer
- Can work remote based in Germany but travel as and when required
Additional Information
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.
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