AdressThe 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.***
