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Compliance and Quality Assurance Consultant

  • Externa annonser
  • Remote Stockholm
  • 2024-07-13

Hemsida 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 Compliance and Quality Assurance Consultant will be key in supporting a variety of Life science 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; providing key support to a range of clients in QA and acting as a Qualified Person/Responsible Person. This role will allow the successful applicant the chance to work on some of the most fascinating projects the market has to offer with the opportunity to fast-track your development across various therapeutic disciplines. In addition, ProPharma also has the opportunity to offer remote working; a competitive remuneration package and a positive work-life balance.
Essential Functions Include:
  • The Compliance & Quality Assurance (CQA) Consultant position is primarily responsible for being a key Subject matter expert in assigned areas of quality assurance and regulatory/GxP.
  • They will be responsible for providing Independent consultation with clients and project leadership to a range of challenging and fascinating projects across the CQA space.
  • 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
  • Carry out batch certification and release of batches as QP on behalf of clients (if applicable) and other QP duties, as applicable.
  • Lead and manage project work on client’s WDA projects, such as acting as an RP, GxP auditing, developing Quality Management Systems (QMS) etc.
  • Ensure the successful execution of key projects and ensure profitability
  • Keep pace with the regulatory and technological changes in the CQA field
  • Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.
  • Actively promote CQA services within the industry across various platforms
  • Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
  • Provide CQA specific training to clients and associates within other business units.
  • Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise.
  • Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
  • Directly engages with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.
  • Other duties as assigned
Experience required
  • Ideally educated to at least a BSc level in Pharmacy or another appropriate discipline
  • Must hold 6 years or more experience within Quality Assurance within GXP settings
  • 1-2 years or more experience working as a Qualified Person is required
  • Ideally skilled in development and marketed products
  • Thorough understanding of the Regulatory landscape within the industry
  • Fluency in English and ideally Sweden
  • 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.***
  • Externa annonser
  • Remote Stockholm
  • 2024-07-13

Hemsida ProPharma Group

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