17641-QA Specialist-Carlow Contractor

This is an 11-month contract.

Purpose:

As Quality Assurance Specialist you will ensure that the manufacturing and associated processes for vaccines and biologics are in compliance with cGMPs and regulatory requirements. You will be responsible for reviewing and approving documentation to support corporate compliance / regulatory expectations for equipment and utility qualification, supporting the site Quality Assurance function in ensuring that an effective quality system is in place. You may also be required to effectively manage and provide stewardship of assigned Quality Systems ensuring that objectives are effectively achieved, and consistent with company requirements to ensure compliance, safety, and reliable supply to our customers.

Responsibilities:

• Responsible for supporting equipment qualification/ requalification through review and approval of pre and post-execution protocols.
• Responsible for supporting deviation close out for assigned areas and initiating/following up on corrective and preventative actions.
• Drive compliance with company Global Policies, Procedures and Guidelines, and regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis, including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries, etc.; thereby ensuring the department is audit/inspection ready.
• Actively participate in Plant/Quality committees and work with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set the direction for plant-wide GMP initiatives.
• Support the development and implementation of improved quality reporting measures for areas of ownership. Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete, reviewed on a continuous basis.
• Ability to make rapid and informed Quality decisions.
• Be an advocate of continuous improvement in Quality Management Systems.
• Conduct self-inspections and support external audits as appropriate.
• Review and verify site documentation that may be used for regulatory submissions/filings.
• Assure the accuracy and integrity of all data and information through timely review and approval.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• Review and approval of Change Controls, and QMS documents as required.
• Drive effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for related systems; ensure all work is subsequently carried out in line with same.
• Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s, etc.; oversee and implement subsequent corrective action through the change management system.

Minimum Qualifications & Requirements:

• Bachelor’s Degree or higher preferred: ideally in a related Science  Discipline
• 5 – 8 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment
• Equipment and process validation
• Knowledge of regulatory/code requirements for Irish, European and International Codes, Standards, and Practices
• Experience with Sterile filling processes and equipment and associated GxP requirements
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
• Proven decision-making capability with accountability and responsibility
• Report, standards, and policy writing skills required
• Proficiency in Microsoft Office and job-related computer applications required