QA Validation Compliance Specialist

CAREERWISE RECRUITMENT

LIMERICK

A QA Validation Compliance Specialist is required for a Limerick based client (initial 12-month contract). In this role, you will provide support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as CCs, NOEs, EOEs and CAPAs. You will also support the development and implementation of appropriate compliance related policies and procedures for QA Validation. ROLE: * Provide support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as CCs, NOEs, EOEs and CAPAs. * Provide tracking and trending for all QA Validation related compliance activities i.e NOEs, EOEs, CAPAs, Change Controls, Audit Actions etc. * Generate weekly/monthly management reports for compliance metrics. * Supports the development and implementation of appropriate compliance related policies and procedures for QA Validation. * Reviews procedures, policies and other instructional documents relating to QA Validation to ensure compliance with company policy and local and international regulatory requirements. * Coordinate training requirements for QA Validation personnel on regulatory and quality topics such as good documentation practices. * Act as department Compliance representative for QA Validation when collaborating with functional departments to resolve issues and maintain compliance. * Participates in the preparation and support of regulatory and customer audits. REQUIREMENTS: * Requires BSc/BA in scientific discipline or related field with 3 years of relevant work experience in pharmaceutical or related industry, in a cGMP environment. Additional related work experience will be substituted for educational requirement. * Quality and/or Validation experience essential. * Understanding of technical terminology commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation. This is an excellent opportunity to join a great team within a large company. This role is with a leading company that is consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Please contact Michelle Galvin on (091 373 938) mgalvin@careerwise.ie for further information on this exciting new opportunity. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1663 days ago