* 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.
* 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.
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The Life Science Specialists