Senior QA Specialist (2yr FTC)

Careerwise Recruitment

Cork

SENIOR QUALITY ASSURANCE SPECIALIST required by CareerWise Recruitment for our multinational Pharmaceutical client in Co. Cork. Two year Fixed Term Contract on offer. The SENIOR QUALITY ASSURANCE SPECIALIST will provide Quality oversight, support and expertise to GMP related activities and Quality Systems in the Biologics Integrated Process Team (IPT) and in meeting the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan. THE ROLE: * Support start-up activities from a quality aspect to ensure compliance. * Support all quality and compliance requirements for the Biologics Integrated Process Team (IPT) to enable batch disposition for each batch manufactured. * Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks. * Coordinates the work of others within the team. * Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality. * Active member/Lead (as required) within the cross functional IPT team providing quality expertise, support and advice to the IPT team on Quality Assurance and GMP compliance aspects. *Works within IPT to ensure supply of high quality product through implementation and oversight of the Quality Management System. * Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes. * Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. * Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site. * Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable. * Champion Permanent Inspection Readiness (PIR) for the Biologics IPT. * Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality. * Act as quality sign-off/designee for the Biologics IPT Quality Lead, as required. REQUIREMENTS: * At least 5 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality Assurance/Quality Operations function. * Degree in Science, Engineering or similiar. * Green belt or suitable alternative (desirable. * Good communication & interpersonal skills. Please call Conor Twomey today for further information on 021-4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2248 days ago