Quality Assurance Coordinator

Quality Assurance Coordinator required for Pharmaceutical client based in Shannon,. Co. Clare.

Responsibilities:

• Monitor supplier GMP / GDP licenses – Source replacements as required.
• Maintain the QMS documents (Document Review, Document Control).
• Maintain Customer / Supplier Technical Quality Agreements (TQAs).
• Monitor / Support customer complaints.
• Perform the release of diagnostic products to shipping.
• Perform Start-of-Batch checks and in process inspections.
• Perform Incoming Inspection including physical verification of packaging materials to ensure they meet quality standards.
• Perform Documentation initiation request / document change request review.
• Follow up the execution of Line Clearances.
• Review lot Range Data and communicate it to production.
• Archive of batch records and retain samples.
• Manage pharmaceutical Supply Chain Maps (SCMs) and associated Technical Quality Agreements (TQAs).
• Prepare and submit annual GDP license updates to the HPRA.
• Support periodic GMP / GDP audits by HPRA.
• Prepare annual Periodic Quality Review reports.
• Prepare Annual Internal / External audit schedules and lead / support associated audits.
• Support annual ISO 13485 surveillance / recertification.
• Manage supplier regulatory licenses (GMP / GDP / WC).
• Manage Deviations / MRB.
• Manage Risk Assessment process.
• Perform required internal investigations and drafting reports.
• Manage Product Master Files and Bills of Materials.
• Manage Customer (/Supplier) Artwork for new product introductions and revisions.
• Support (/Review) equipment Validations (RA, URS, Protocols, Reports, etc.).

Requirements:

• Good inter-personal skills.
• Strong Oral and Written Communication Skills at all levels of the organization.
• Good Technical writing skills.
• Experience of HPRA GMP / GDP requirements.
• Experience of Medical Device secondary packaging,
• Bulk Pharmaceutical Distribution an advantage.
• Qualified Internal Auditor, or External Auditor training an advantage.
• Qualification in Quality Management, Engineering, Business Management, Business Administration or related field is preferable.
• Good PC skills such as Excel (Slicers, PowerQuery, Functions, and Macros), Word, PowerPoint, Power BI (Dashboard generation, PowerQuery) an advantage.

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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