Overview
QA Specialists Jobs in Waterford Metropolitan Area at Prochem Engineering
Title: QA Specialists
Company: Prochem Engineering
Location: Waterford Metropolitan Area
QA Specialists required for a pharmaceutical client based in Waterford
Job Purpose:
- Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
- Support the development of GMP training packages and delivery of training
- Participate in the preparation and review of procedures and batch documentation
- Perform audits of all departments to agreed schedule
- Ensure the quality system at Genzyme is effectively implemented and maintained
- Ensure practices meet cGMP requirements
Job Requirements
- Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
- Perform timely review of documentation / investigations /reports highlighting and assisting in the resolution of concerns commensurate with the risk
- Work with relevant departments to ensure timely closure of quality actions / findings
- Actively contribute to continuous improvement initiatives.
- Conduct duties in a safe manner and report all safety issues or concerns
- Maintain work area to good housekeeping standards
- Ensure attendance at place of work when required
- Support team in achieving team goals/targets
- Attend team meetings as required
- Actively contribute to continuous improvement initiatives
- Measure and report RFT / trend data and work with departments to resolve recurring issues
- Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
- Perform critical/ constructive review of procedures and practices
- Support investigation of deviations ensuring all product deviations are closed prior to product release
- Ensure compliance to cGMP at all times
Qualifications and Experience
- Third Level qualification (degree in science or related discipline preferred).
- Minimum of 2 years’ experience in a similar role
- Experience working in a GMP environment is required
- Very good knowledge of cGMP in a regulated environment
- Excellent accuracy and attention to detail
- Excellent interpersonal skills
- Good presentation skills
- Working knowledge of computer packages
- Flexible approach – comfortable with on-going change
