Supply Chain Disruption Quality Specialist
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Hobson Prior currently have a new 12-month contract position at a specialty biopharmaceutical company in Dublin. Our client is looking for a Supply Chain Disruption Quality Specialist to be accountable for documentation management and managing all of the organisation's quality systems.
Quality System Management:
- To ensure all quality systems are addressed and resolved in a timely manner to minimize impact on product supply.
- To ensure Transportation processes are in line with GDP guidelines, regulatory and quality requirements.
- Manage Deviations, CAPAs and Change controls for commercial and non-commercial shipments.
- Lead and manage temperature deviations to closure and within established timelines.
- Develop and revise documentation such as procedures, work instructions and job aids applicable to 3PL replenishment, CMO Transportation and Non-Commercial shipments.
- Ensure all documentation, with both internal and external partners, are up to date and reflect the current process.
- Revise internal procedures as needed to maintain a robust process for supplying drug products to the organisation's patients in a compliant manner.
- Promote GDP compliance and Cold Chain excellence related to Cold Chain validation documentation and Validation testing.
- Support training development and conduct training for internal employees and external service providers.
- Recognise Gaps in current transportation processes and develop and implement appropriate updates as needed.
- Support External Audits as it relates to Freight Forwarder storage and TSA screening facilities, CMOs, Distribution centers and Supply Chain Vendors.
- Support Internal Audits on Transportation procedures and all quality systems within Trackwise.
- Fluent in English in verbal and written communication.
- Proficient in writing and compiling concise documentation.
- Strong organization skills and attention to details.
- Exceptional oral skills and written communication skills
- Ability to work with both independently and in a cross-functional environment including external service providers.
- Excellent time management skills.
- BA/BS in related field with Minimum 3+ working in a cGMP environment.
- Experience conducting investigations, working knowledge of logistics and experience with temperature sensitive product distribution.
- Experience in Trackwise is preferred.
- Previous technical writing is preferred.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€55 - €75 per hour
Hobson Prior currently have a new 12-month contract position for an External Technical Services Lead EU to join a patient-focused pharmaceutical organisation in Dublin.