Senior Compliance & Quality Assurance Consultant – QP – ProPharma Group – Leiden

  • Leiden

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.

The role

The Senior Consultant – Compliance and Quality Assurance (QP) will be key in supporting a range of clients across various phases of development and commericalisation within Pharmaceutical and Biological industry. Within these projects, the successful candidate will be responsible for strategic development; project leadership; acting as the SME and providing key support to operational tasks linked to Quality Assurance activities within different settings.

  • Acting as the QP/RP and other QA functions as required

  • Provide strategic advice, project management, auditing, tech transfers and qualification/validation support

  • Oversee and maintain the Quality Management System for assigned clients, as applicable.

  • Conduct audits and participate during regulatory inspections for clients in collaboration with the authorities.

  • Provide internal and external training/education.

  • Carry out batch certification and release of batches as QP on behalf of clients (if applicable) and other QP duties, as applicable.

  • Lead WDA/MIA applications including writing the QMS and applications to the competent authority.

  • Be named on MIA or WDA as Qualified Person or Responsible Person

  • Work on a broad variety of projects from launch to mature products.

  • Identify bottlenecks and propose solutions in consultation with the client.

  • Build and maintain relationships with existing clients to broaden or strengthen the relationship.

  • Maintain an awareness of current legislation and guidance associated with GxP requirements

  • Ideally educated to at least a BSc level in Pharmacy or another appropriate discipline

  • At least 10-15 years working with the life-sciences industry

  • 4 years or more experience working as a Qualified Person

  • Can demonstrated experience within development (R&D) and commercial settings as QP or RP

  • Thorough understanding of requirements for GMP and GDP in the EU

  • Fluency in English and Dutch

  • Demonstrated project management skills with the ability to prioritise workload and meet deadlines.

  • Excellent collaboration and 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.***

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