Description
Global healthcare company seek Quality specialist for 12 month fixed term contract.Reporting to the QA Systems Manager, the primary function of the Quality Specialist is to assist in maintaining the quality system. The role can have responsibility for one or more of the following processes:
- Batch release
- Complaints
- Label development
- In Plant instruction development
- Metric maintenance
- Training system administration
Major Responsibilities
- Assist with administration and ensuring compliance to Quality Management Systems including:
- Complaints, Batch Release, Exception Reports, CAPA, Document Control, Training, Label development, In plant Instruction development, Metric etc.
- Assist with other support duties as assigned.
- Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
- Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
- Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
- Maintains and analyzes product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues.
- Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
- Collaborates with members of the Quality Assurance team working on special projects.
- Participate on permanent and temporary teams which are process or project driven.
- Become familiar and subject matter expert on electronic support systems, Prima, GQMS, QDMS, compliance wire etc.
- Coordinate label development and implementation with key stakeholder including but not limited to affiliate, manufacturer and label supplier.
- Collect analysis and publish quality metrics.
- Provide data for support of budgetary submissions.
Education
- A third level qualification, or equivalent industry experience required, preferably in a Quality associated topic(s)
Background
- Must have 2 or more years of direct experience in a Quality or Regulatory Affairs role in a GMP related industry.
- Experience in label development desirable.
This is a 12 month fixed term contract with a competitive salary and benefits package; it is an urgent requirement so interviews will take place immediately. Contact me Anna Mooney to hear more.