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Details

Global Quality Master Data Specialist


Reference:AXFB-128474 Location: Dublin
Qualification:MastersExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Content Specialist, Data Management

Global Quality Master Data Specialist
Our client, a global healthcare organisation, requires a Global Quality Master Data Specialist to join their team for a 6 month fixed term contract. This is an excellent opportunity to work within the growing biologics space in Ireland.

Responsibilities
• Provide Quality Oversight for Compliant Master Data in Data Integrity and in accordance with all Regulatory requirements
• Review and approve Product and Material Master Data and Registered Attributes in SAP Systems as well as representing Global Quality in all projects and initiatives that impact Master Data across the organisation
• Review Global Master Data Material Code requests for Active, Bulk, Partially Packed and Finished Dosage forms to ensure that all Identification Codes are unique and comply with all requirements as specified
• Review modifications to Product Registered Attributes in SAP (e.g. Shelf Life) to ensure compliance with Marketing Authorisation Details etc.,
• Perform risk analysis and impact analysis for modification to existing Global Material Codes to ensure that any changes are completed in compliance with all Regulatory requirements (both Local and Global)
• Support the Global Master Data Group and local Sites for any System Integrations which impact the SAP System and represent Global Quality Master Data to ensure our standards are applied appropriately
• Perform and lead investigations into Master Data related issues by reviewing data reports and all sources applicable and work with the necessary Groups to identify any impact and apply a resolution
• Represent Global Quality Master Data in all matters to ensure standards are consistently applied for any items relating to Master Data which has the capacity to impact Quality or Regulatory compliance
• Support and oversee Global Vendor and Customer Master Data to ensure compliance with any Site Licence or other Requirements as applicable
• Complete GMP training with all Users who use Master Data in SAP on Global Quality Master Data requirements for compliant Master Data, and support any Health Authority or Other Inspections for any items relating specifically to Global Master Data.

Requirements
• Bachelors degree qualification (science related discipline an advantage)
• 3 years Quality/Regulatory experience in a pharmaceutical environment, and 2 years IT/SAP/Data Analytics Experience is preferred. A combination of qualifications and experience will be considered
• Solid attention to detail and the ability to escalate and resolve discrepancies or issues with urgency
• Familiarity with Regulatory Requirements pertaining to EMA, FDA, WHO and other major Worldwide Regulators and Universal Guidance's
• Knowledge of the requirements pertaining to Regulatory Applications and associated Marketing authorisations, and knowledge of the Regulatory Submissions Process is an advantage
• Strong communication skills (both written and oral), with an ability to create presentation materials to demonstrate findings or specific topics when needed
• Ability to be a team player and work effectively and diplomatically with our colleagues is a skill that is highly valued in this role
• Ability to work independently and to use your own initiative, and experience in Training is desired



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

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