Location
Merthyr Tydfil, Wales | United Kingdom
Job description
ABOUT US
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.
THE ROLE
We are looking for a Qualified Person to join our IMP Management Department where you will be responsible for assuring the quality of Investigational Medicinal Product (IMP) through performing final certification of the finished IMP. Qualified Person oversight of the importation of finished IMP from approved countries for import. Will provide Good Manufacturing Process (GMP) expertise to colleagues and clients.
KEY ACCOUNTABILITIES
- Performs final QP certification of the finished IMP, including batch documentation reviews and visual inspection, ensuring compliance with any specific expectations for GMP as per the CTA and IMPD registered details.
- QP Oversight of the importation of finished IMP from an approved country for import.
- Creates and reviews Investigational Medicinal Product Dossiers (IMPDs).
- Line-manage, and provide leadership, coaching, and mentoring to ensure effective people development.
- Provides pharmaceutical input and advice on protocols, Clinical Trial Authorisations (CTAs) and Requests for Proposals (RFPs)/Requests for Information (RFIs).
- Conduct supplier approval assessments and audits.
- Works within and supports the continuous improvement of QMS, including writing/reviewing/approving SOPs, change controls, deviations, technical agreements, production records, and labels.
- Proactively contributes to quarterly/annual review of the GMP Pharmaceutical Quality System.
- Represents Simbec-Orion at meetings with clients and regulatory bodies.
- Deputise for the Head of IMP Management and QA Pharmacist as required.
SKILLS REQUIRED
ESSENTIAL: - Eligible to act as a QP and be suitable for nomination to act under a Simbec’s MIA(IMP)
- Degree in Science Subject or overseas equivalent
- Extensive experience working in a GMP environment
- Extensive experience in dealing with clients, providing technical Chemistry, Manufacture and Controls (CMC) advice
- Previous experience in dealing with inspections and audits
- Excellent verbal and written communication, fluent in English
- Experience as a Line Manager
DESIRABLE: - Medical or scientific qualification (MSc, PhD, PharmD or MD)
- Previous experience as a Qualified Person
- Auditing experience to Good Manufacturing Practice standards
- Audit Qualification, e.g. IRCA (International Register of Certificated Auditors) accredited
- Previous experience within a Clinical Trial environment
- Experience in business development activities, including CMC advice and participation in proposal development and bid-defence meetings
- Previous experience in writing documents for regulatory submissions e.g. Investigational Medicinal Product Dossiers (IMPDs)
- Experience or good understanding of handling and preparation of Radiopharmaceuticals
- Experience in analytical QC or Microbiology QC
WHY YOU SHOULD JOIN US
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.
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