Company Overview:
Founded in 2005, At RxSource, our purpose is to improve the lives of patients. We provide Clinical Trial Supply Chain Services and Pharmaceutical Procurement globally. With offices in Canada, the USA, and Ireland, we deliver tailored services to Pharmaceutical Sponsors, Biotechs, and CROs. Our team and culture are our most valuable assets, embodying our core values in everything we do. We see our clients as partners, and their success is our success
Position Summary:
* We are seeking a highly skilled
Qualified Person (QP)
to support the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU GMP, Annex 13, Annex 16, and applicable national legislation. This role is critical in ensuring product quality, patient safety, and the integrity of clinical trial supply chains. The ideal candidate will be Detail‑oriented with strong decision‑making and risk‑based thinking. They will be confident in interpreting complex quality and regulatory requirements. They must have strong communication skills and be able to work cross‑functionally with QA, QC, manufacturing, and supply‑chain partners.
What you will do:
As the certifying QP, you will be responsible for ensuring that each batch released for clinical trial use meets all regulatory, quality, and compliance standards, including:
* Certifying batches in line with the Manufacturing/Importation Authorization (MIA) and national regulations.
* Ensuring all manufacturing, testing, and supply‑chain activities comply with EU GMP and the IMPD/CTA requirements.
* Verifying that full supply‑chain documentation—from starting materials to finished product—is complete, controlled, and compliant.
* Confirming that manufacturing/testing sites used for the batch meet EU GMP requirements and relevant Annexes.
* Ensuring all records, in‑process checks, investigations, and validations are complete and appropriately approved.
* Reviewing and confirming the suitability of starting and packaging materials, including TSE compliance where applicable.
* Ensuring QC data meets the Finished Product Specification and that ongoing stability supports release.
* Confirming supplier qualification, technical agreements, training records, and self‑inspection programs are current and effective.
* Ensuring appropriate distribution arrangements are in place for certified batches.
* Ensure appropriate oversight of any delegated QP-related activities and maintain documented justification and controls in line with EU GMP expectations.
Note: Where responsibilities are delegated, the certifying QP retains full accountability for batch certification.
Additional Expectations
* Act as a named QP on the MIA and perform QP duties as described in site SOPs and QTAs.
* Maintain up‑to‑date training and expertise aligned to regulatory expectations and product requirements
.
* Responsible for all inbound and outbound shipments including client specific request.
* Receive inbound products as per procedure and store products in appropriate temperature storage conditions.
* Update the inventory logs and update the ERP system for inbound and outbound products.
* Inspect clients incoming shippers, conditioning and storing.
* Preparation, Handling, labeling & packaging of shipments.
* Perform conditioning of the temp-controlled shippers and gel packs.
* Complete Destruction list of expired products monthly.
* Responsible for daily updates of the temperature monitor log sheet.
* Ensure appropriate SOP forms are completed when required for audit documentation purposes.
* Responsible for notifying QA of any issues that may impact the quality and integrity of the products.
* Responsible for dispatching and prioritizing shipping schedules as instructed.
* Assist in mitigating risk and in resolving any issues with shipments (e.g., delayed shipments).
* Assist with auditing to ensure accuracy of product and logs.
Your Skills, Qualifications and Experience:
* Postgraduate Diploma or MSc meeting the educational criteria outlined in EU Directives 2001/82/EC and 2001/83/EC.
* Demonstrated experience within GMP environments, ideally within clinical supply or IMP manufacturing.
* Strong understanding of EU GMP Annex 13, Annex 16, and IMPD/CTA frameworks.
* Ability to prioritize and meet deadlines in a fast-paced environment
No matter your role at RxSource, successful team members are:
* Patient Champions, who put patients first and uphold strict ethical standards
* Achievers, who drive toward practical solutions
* Individuals Who Inspire Excellence in themselves and those around them
* High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed