Quality Assurance Specialist
About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. A beautiful county is the south east region of Ireland, with the River Barrow flowing through the town; Carlow is home to its renowned Institute of Technology. It’s a great base if you want to be out of the hustle and bustle of the city but easy to reach Wexford, Kilkenny, Wicklow, Kildare, Laois & Dublin. Your Job Purpose. Responsible for ensuring that the manufacturing processes for vaccines and biologics are in compliance with cGMPs and associated regulatory requirements. Responsibilities. Reviewing and approving documentation to support corporate compliance / regulatory expectations for manufacturing, and supporting the site Quality Assurance function in ensuring that an effective internal and external auditing program is in place. Responsible for the effective management and stewardship of assigned Quality Systems. Responsible for ensuring that objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and reliable supply to our customers. Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Support the development and implementation of improved quality reporting measures. Carry out annual product reviews. Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. Support the application and management of site license. Ensure reliability and performance by facilitating effective systems for identification of root cause failures, recommendations and implementation of improvement changes throughout processes, ensuring calibrations of equipment are performed as necessary. Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Requirements. Bachelors Degree or higher preferred; ideally in a related Science discipline, Engineering or other Technical Discipline. Six Sigma qualification preferred. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Extensive knowledge of the following systems: o Change Control. o Deviation Management. o Self-Inspections. Knowledge of cGMP and GDP required. Report, standards, policy writing skills required. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job related computer applications required. Lean Six Sigma Methodology experience desired. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Refer someone you know for this role and if we hire them you will receive a €250 voucher. (T’s & C’s apply) Click on the following link to Refer Your Friend today! http://www.lotusworks.com/en-ie/refer-a-friend. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email email@example.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2018. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
131 days ago