Regulatory Affairs Specialist
4 weeks ago
Regulatory Affairs Specialist (QP)
RBW Consulting is currently seeking a dedicated Regulatory Affairs Specialist to join a dynamic team focused on the development and production of advanced sterile products. This role is pivotal as the organization embarks on an exciting phase of growth and innovation.
The company is renowned for its expertise in aseptic and terminally sterile environments, and is actively expanding its product offerings. This growth has necessitated an increase in personnel, particularly at the leadership level. The organization is also investing in new technologies, exploring opportunities for site expansion, and implementing a state-of-the-art electronic Quality Management System (eQMS).
The Regulatory Affairs Specialist will engage in technically oriented responsibilities without direct management duties, while also having the chance to participate in various quality-related initiatives and contribute expertise across multiple evolving sectors of the business.
While initial training will require on-site presence, there is flexibility for remote work due to the established remote release framework. However, given the scale of operations and team expansion, some on-site engagement will be anticipated.
Key Qualifications:
- Must possess eligible QP status within the UK
- Experience in sterile manufacturing is preferred but not mandatory
- Eligibility as a Responsible Person (RP) is advantageous but not required
- Strong interpersonal skills with the ability to thrive in a small, agile team environment
- Willingness to travel for training and occasional site visits as necessary
If you are interested in learning more about this opportunity, please reach out for further details.
Keywords: QP, qualified, regulatory, affairs, GMP, manufacturing, sterile, terminally, sterility, aseptic, quality, assurance, compliance, audit, release
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