- Reference: 46512
- Job Type: Permanent
- Location: Roscommon, Westmeath
- Category: Science, Pharmaceutical & Food
Responsible for providing quality systems support for to all processes related to QMS. Assures that quality standards are maintained and assist with the implementation and compliance of the quality management program.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Quality system support
- Change Control System / Document Control
- Manage and compile QA data for monthly Metrics review
- Create, maintain and complete internal auditing schedule
- Support Management review and Management of external 3rd party audits.
Quality Systems Complaints / CAPA / NCRs
- Manage the recording, investigation and resolution of product complaints, product problems, or safety issues.
- Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting
- Generate KPI data around Complaint, CAPA, NCR and continuous improvement
- Provide support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates.
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
Regulatory Affairs Support
- Provide support to RA with all international country submissions
- Provide support to solve and reply to any regulatory query.
- Help to manage and maintain all RA documentation including Technical Master File
- Support the preparation of change notifications/Validation protocols and Reports.
- Provide ongoing manufacture support in order to help the team meet its business objectives.
- Provide Quality role in new product introduction and transfers to production.
- level 8 Degree in a releavant discipline
- Previous work experience in a similar work environment is essential.:
- Experience in working in High Volume Production Facility
- Strong computer skills – Change control management; design, process and system.
- Familiarity with ISO quality systems ( ISO13485 – 21 CFR 820)
- Risk Management including FMEA generation
For more information or to apply please contact Tina Egan on firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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