Quality Npi Engineer
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. Working with the LotusWorks team as a Quality/NPI Engineer, you will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities. Responsibilities. Ensuring that the process for the introduction of biologics/vaccines follows cGMP and the associated regulatory requirements. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. Provide quality oversight and direction for the introduction of new products and drug substance onto site covering the end to end strategy. Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings. Participate as functional expert in the cross functional team that manages introduction of products. Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Facilitate batch release strategy between supply, manufacturing and packaging sites. Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation. Review other documentation associated with new product and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.) Requirements. Bachelor’s degree in engineering, Science or relevant discipline. Minimum of 5 years’ experience working in a similar environment. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP and GDP preferred. 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 2017. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
97 days ago