Quality Specialist

3 weeks ago

Carlow Town Co Carlow, Ireland RT Lane Ltd Recruitment Full time

R.T. Lane Recruitment are currently recruiting for a QA Specialist QMS to work with a pharmaceutical company based in Carlow. **Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance** This is an 11-month contract with strong potential for extension. 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. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements. Essential Criteria: 3 - 5 years experience in a pharmaceutical/ regulated background with strong working knowledge of regulatory expectations, aseptic processing, environmental and utility monitoring in a sterile manufacturing facility. Roles and responsibilities: 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 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. 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 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: To excel in this role, you will more than likely have: Bachelor Degree or higher in a related Science discipline Knowledge of EU quality related pharmaceutical regulations Experience of Sterile manufacture preferred Knowledgeable in Industry Best Practices for quality and compliance related topics Strong verbal and written communication skills, project management skills Equipment and process validation Lean Six Sigma Methodology experience desired 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 Please note due to a high volume of applicants you will only be contacted if suitable for the position. For more information or a full Job Description please contact Michelle Power, R.T. Lane Recruitment on or email Skills: Pharmaceutical quality QA management GDP Management Quality Systems Good Documentation Practices Manage quality Benefits: Paid Holidays

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