We are currently hiring a QA Specialist, who will be working in a cGMP regulatory environment.
Reporting to AD Quality Systems and Compliance, the QA Specialist will be responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
Partner with colleagues cross functionally/ on and off site to provide support and advice on day-to-day basis and on a project, basis including communications, training, project work, audit/inspection duties, investigations, systems compliance etc.; thereby ensuring department/site is audit/inspection ready.
Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements.
The ideal candidate will have 3 - 5 year’s experience in a pharmaceutical/ regulated background with strong working knowledge of regulatory expectations, aseptic processing, environmental and utility monitoring in a sterile manufacturing facility.
The role will support quality systems, monitoring and management and will liaise with technical subject matter experts from other company sites as well as participate in above site technical forums. The role will provide technical expertise, troubleshooting, training and support activities to different areas such as laboratories, facilities, warehouse, validation etc.
Bring energy, knowledge, innovation to carry out the following:
· Responsible for ensuring that the quality systems in use at the Carlow site are in compliance with cGMP and the associated regulatory requirements
· Act as site lead for nominated quality systems (e.g. EDMS, Deviations, CAPA, Quality Management etc), responsible for trending review and resolution of issues
· Ensure that quality issues are identified, addressed and resolved in a timely manner
· Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed
· Support the development and implementation of improved quality reporting measures
· Aid the effective implementation of the relevant areas of Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete, review on a continuous basis
· Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same
· Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations etc
· Ensure that quality issues are identified, addressed and resolved in a timely manner
· Actively participate in Plant/Quality committees and work with other site functional groups to help set direction for QMS related topics
· Liaise with technical subject matter experts from other company sites as well as participate in above site technical forums
What skills you will need:
In order to excel in this role, you will more than likely have:
· Bachelor Degree or higher preferred; ideally in a related Science discipline
· Knowledge of EU/US quality related pharmaceutical regulations
· Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing GMP setting
· Experience of Sterile manufacture preferred
· Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing roles
· Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices requirements.
· Knowledgeable in Industry Best Practices for quality and compliance related topics
· Proven ability to effectively initiate and drive change
· Strong verbal and written communication skills, project management skills
· Report, standards, policy writing skills required
· Equipment and process validation
· Proficiency in Microsoft Office and job-related computer applications required
· Lean Six Sigma Methodology experience desired
· Good Collaboration Skills
· Ability to work as part of a team to determine priorities
· Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
· Demonstrated ability to drive the completion of tasks
· Proven decision-making capability with accountability and responsibility
· Demonstrated ability to solve problems
