QA Validation Compliance Specialist
QA VALIDATION COMPLIANCE SPECIALIST required by CareerWise Recruitment for our BioTech client in the mid-west region. The QA VALIDATION COMPLIANCE SPECIALIST will maintain compliance of the QA Validation cGMP Compliance, Training and Audit function for the QA Validation Department. THE 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. * Actively participate in continuous improvement initiatives. * Participates in the preparation and support of regulatory and customer audits. * Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into our clients systems. * Training of QA Validation personnel on related disciplines within QA Validation. * Participate in investigations and root cause analysis for all QA Validation Department issues of non-compliance. * Work with cross-site teams to support standardization of QA Validation practices. * Follow current good manufacturing practices (cGMPs. * Promotes a GxP and Quality mindset at all levels. * Ability to easily adapt to changing needs of the company. 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. Please call Conor Twomey today for further information on 021-4297422 or email: firstname.lastname@example.org. 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.
247 days ago