QA Specialist - Supplier Quality

We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Support of planning, execution, and documentation of the qualification and monitoring for suppliers who are sourcing APIs, API materials or DP materials such as excipients, raw or packaging materials, to the Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
• Support Surveillance on the quality and compliance status for all suppliers of raw materials, packaging materials, intermediates, excipients, and APIs.

1. Support of Management of Change related to supplier (change assessor, action executioner,)
2. Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning materials received from suppliers
3. Provision of all information needed for the release/reject of suppliers in SAP (SAP master data) and SAP Material approval /AML updates for LM.
4. Support Establishment of Quality requirements and Quality agreements and periodic review of Quality Agreements
5. Support account owners for initial assessment and qualification of suppliers for new product introductions, and establishment of initial Qualification Statements
6. Support Periodic performance measurement for suppliers
7. Provide support local Sites during Customer and HA inspections as needed
8. Support supplier Specification agreement and approval management

Education & Experience

• 3 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment
• Familiar with GMP – and International Conference on Harmonization ( ICH ) – regulation
• Trackwise and SAP experience would be desirable
• Exposure to regulatory authorities’ inspections


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.