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Details

Senior Qualified Person


Reference:AIJT-281117 Location: Cork
Qualification:MastersExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Senior Qualified Person
Our client, a global biopharmaceutical company are currently recruiting for a Senior Qualified Person to join their team on a permanent basis. The ideal candidate for this role will have experience as a named QP on a manufacturing license. This role is based in Cork, and has excellent career progression opportunities.

Responsibilities
• Responsible for certifying batches prior to release to filling site
• Ensure that the batch and its manufacture comply with GDP, GMP, Marketing authorization, IMPD & Import Licenses depending on the product requirements
• Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
• Ensure that all necessary tests and checks have been performed prior to batch release
• Ensure that all necessary production and quality control documentation has been completed and endorsed by authorized staff
• Attend QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
• Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract test labs
• If a new product type is introduced the QP should ensure that they have gained the relevant knowledge and experience necessary to complete QP duties
• Maintain oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required
• Supports QA colleagues with product quality / license impact assessment for deviations

Requirements
• MSc or Higher Diploma in Pharmaceutical Sciences/ Pharmaceutical Manufacturing Technology which fulfills the QP educational requirements
• Industry experience within a QP role within a regulated biologics or pharma industry
• Knowledgeable of FDA/EMA regulatory requirements
• Excellent social and communication skills
• Self-driven and keeps up to date with regulatory, technical developments within the industry
• Acute attention to detail
• Focus on patients and customers at all times


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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