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QA Packaging Specialist

Quality & Laboratory
Dublin North
Siobhán Lane
Temporary
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Job Reference: JO-2005-65179_1588848166

Summary:


Responsibilities


* Responsible for Quality oversight, with management support of internal packaging, warehousing operations combination products, clinical, validation verification and quality control on site.


* Co-ordinate the QA Finished Product team and liaise with peer internal Quality Groups to ensure on-time disposition of Finished Product.


* Provide Quality support to QC department to include method transfer or validation/verification activities and LIR review and approval.


* Provide oversight to continuous quality system improvements and support implementation of improvements at College Park in compliance, calibration, Preventive Maintenance, Deviation Management and the Change Control Programs.


* Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews related to College Park operations.


* Provide QA and compliance support to projects impacting on packaging activities.


* Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.


* Responsible for quality review and approval of Master Packaging Batch Records in accordance with internal procedures and GMP principles.


* Review and approval of standard operating procedures and controlled documents.


* Define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to packaging operations.



Requirements


* Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)


* Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility


* Minimum 3 years of experience in QA labelling and packaging/combination products and/or QC


* Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements


* Demonstrated success records in auditing and improvement processes


* Ability to operate efficiently in a complex matrix organization and international environment


* Management skills for management of a team of experts,


* Strong mature leadership and interpersonal influencing skills


* Ability to represent the company and to negotiate at different levels contacts both internally and externally


* Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels


* English fluency written and spoken (the Company language)


* Efficient in SAP, firstdoc. and Trackwise.



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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