QA Specialist

Desired Skills: quality assurance,packaging,deviations

The role:

PE Global is currently recruiting for a QA Packaging Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 12 month contract.

Job Description:

This position within the QA department provides Quality support and knowledge to activities relating to Quality to meet business priorities. The QA Specialist promotes Quality across cross-functional teams, to deliver high quality products, ensuring continuous process improvement. The QA Specialist models the behaviours and understands the principles to drive a culture of continuous improvement building a High-Performance Organisation

Responsibilities:

• Monitor packaging operations and activities within the QA Group to ensure compliance with GMP, SOPs and company quality standards
• Perform Acceptable Quality Level Inspections on the Packaging Line to verify that Finished Products and Components meet predefined quality criteria.
• Performs QA Release of packaging components by reviewing supplier documentation, verifying compliance with specifications, and ensuring components are fit for use in production. Maintain traceability and accurate records for all released materials.
• Generate and manage Packaging-related paperwork to such as e.g. CCFPs, Barcode Issuance Forms
• Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
• Maintain an organised archiving system for batch records and GMP documentation. Ensure timely filing and retrieval of records to support audits, inspections and internal reviews
• Participate in root-cause analysis and drive corrective and preventative actions
• Assist in investigating customer complaints related to packaging defects or discrepancies. Gather data, analyse findings and support resolution efforts to maintain product quality and patient safety
• Compile and input data for key team performance metrics and and provide accurate reports to support continuous improvement initiatives
• Prioritize tasks to ensure the critical tasks are completed on time and meet requirements.
• Write, review and approve Standard Operating Procedures in accordance with Policies.
• Plan, coordinate and implement packaging related projects within defined objectives and timelines. Collaborate with cross functional teams to achieve project goals and deliverables. Other duties assigned.

Education and Experience:

• Degree or 3rd level qualification (Science, Quality).
• Relevant experience (1yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
• Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
• Proficiency in PC skills such as Excel, Word, PowerPoint.
• Excellent written and verbal communication skills.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.

DESIRED:

• Experience in preparing lot release files
• Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes.
• Evidence of Continuous Professional Development.
• ERP Experience
• Good knowledge of Lean / Continuous Improvement practices and root cause analysis.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***