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.
- 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.
- 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) firstname.lastname@example.org for further information on this exciting new opportunity.
CareerWise Recruitment (In Search of Excellence)