Join RiverArk
At RiverArk, it is our mission to design and execute a pragmatic solution that’s cost effective for our clients whilst being mindful of the external environment and helping to achieve compliance to regulatory expectations.
Our vision is to provide real world bespoke solutions that are both feasible and practical for our clients.
We provide excellence to all our clients by maintaining high standards of professionalism, integrity and communication that ensure we build strong and positive relationships.
Team RiverArk is always on the lookout for like-minded people who resonate with our Mission and Vision.
Join us as a Consultant
With clients located around the world, a globally connected team of consultants, working on exciting projects, a career with RiverArk will take you places!
If this sounds exciting to you, please click here to see the open positions.
GCP QA Consultant
What experience you need to bring onboard:
- Advanced degree in life sciences or scientific discipline
- 5 – 8 years total QA GCP experience (Pharma or Biotech or Medical Devices)
- Regulatory inspection readiness experience (working in a team but not the lead)
- Direct hands-on experience of working on audit planning, execution and delivery (at least 4 years)
Soft Skills you need to possess and practise:
- Ability to identify issues and offer solutions to problems in a pragmatic way
- Good attention to detail, with the ability to see the ‘big picture’
- Highly professional and self-motivated, experience working from home
- Ability to assimilate and analyse information rapidly
- Confidence to work alone or in a team
- Able to communicate easily with Operations team members as well as quality team members
- Articulate issues and situations succinctly
- Assertive
Join Now!
What you will be ‘Responsible’ for:
Auditing
- Coordinate and conduct internal system audits and external investigative site/vendor audits
- Create, maintain, and revise organisations Standard Operating Procedures, forms, and templates
- Evaluates responses to audit reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
QA Systems
- Coordinate, conduct, track, and resolve Corrective Action/Preventative Action (CAPA) completions
- Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records)
- Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization
- Help in developing training materials and applicable tests and guides
- Creating content such as blogs and case studies and whitepapers per instructions from the Director of Operations
Inspection Readiness
- Participate and prepare for GCP inspections at client locations and investigator sites, under supervision
Quality Consulting
- Work alongside experienced quality consultants to understand the issues and problems of clients that need solutions
- Prepare and deliver assigned tasks per Project Manager/Project Director guidance and instructions.
Get in touch here: contactus@riverark.co.uk