ProPharma
Pharmaceutical
Compliance&QualityAssuranceConsultant
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Compliance & Quality Assurance Consultant at ProPharma. Skills: Quality Assurance, Regulatory Compliance, GxP. Support management of compliance projects. Provide consulting services to clients”
What You'll Achieve.
Increase company effectiveness
Industry & Context.
Root cause analysis
Willingness to travel
What They're Looking For.
Must Have
Minimum 5 years relevant experience, Knowledge of US FDA, ICH, EMA, MHRA regulations, Expertise in GxP systems, Bachelor's degree in scientific discipline, Working knowledge of GxP principles, Experience leading audits (if applicable), 5 audits performed in past year (if applicable)
Nice to Have
Graduate degree in scientific discipline, Eligible to be registered as QP/RP/RPi
What You'll Do.
Support management of compliance projects
Provide consulting services to clients
Address quality and regulatory issues
Support GxP compliance projects
Develop subject matter expertise
Contribute to GxP project execution
Participate in sales process
Identify scope and effort for client needs
Support marketing efforts
Develop social media content
Promote continual improvement
Provide CQA training to clients
Provide CQA training to associates
Support clients with GxP issues
Consult for CAPA implementation
Ensure compliance of company operations
Participate in development of quality systems
Educate employees on compliance
Educate employees on quality assurance
Drive continuous improvement
Maintain billable project work
Function as QP/RP/RPi (EU/UK)
Perform QP duties for ProPharma MIA License
How You'll Work.
Team & Collaboration
Critical team member; Engage with employees at all levels; Work with functional units
Communication Scope
Written communication; Oral communication; Interpersonal skills
Process & Methodology
Project planning, Project organization, Project control, Project execution
Full Job Description
For the past 25 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. 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 Compliance and Quality Assurance Consultant (CQA) position is responsible for supporting the management of compliance and quality assurance related projects and providing consulting and contract services to clients to address quality and regulatory / GMP issues, as needed. This position will be assigned to quality assurance and regulatory / GxP compliance projects within the company. The specific facet of GxP project scopes (e.g., GMP, GCP, GLP, etc.) that the individual can be aligned with to support will be dictated by the practical job experience and training reflected in their CV. Typical CQA projects include QMS development, QA oversight, auditing, cell / gene therapies, regulatory agency action response, etc. The Consultant will also be responsible for supporting the design, implementation, monitoring, maintenance, and promotion of ProPharma’s CQA program, policies, and strategies in compliance with GxP regulations and industry trends. **Essential Functions:** * Represent the company in assigned areas of quality assurance and regulatory / GxP. * Provide consultation and support the management of projects within the CQA business practice. * As applicable to project assignment and geographic location, manage and undertake project work on client
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