QA Manager
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| Job Type | Permanent |
| Area | Waterford |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 0806 |
| Job Views | 2237 |
- Description
- Team Horizon is seeking a QA Manager to work on our client’s pharmaceutical manufacturing site in the South-East. In this role you will manage and co-ordinate all Quality Assurance & Quality Systems activities for the company.
What you will be doing:
Support the Head of Quality with the quality department function
Maintain the Quality System to include: People, Premises & Equipment, Production, QC, Outsourced activities, Complaints & Product Recall, Self-Inspection
Have ownership of deviation procedures and approval of investigations
Incidents & Deviations & Complaints
Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
Planned Changes
Manage Self Inspection Program
Manage and facilitate outside Inspections (Customer audits / Regulatory inspections)
Manage manufacturing batch documentation review
Manage Vendor Qualification
Manage API, Excipients & Packaging Components material disposition
Manage batch package preparation for QP release
Be responsible for contract manufacturing organization management
Generate metrics and manage visibility of metrics to Senior management
Manage QA support for all departments: Operations, Engineering, Finance, Regulatory & Clinical Affairs, Business Development, IT, Technical Services, Research & Innovation
Attend a number of cross functional team meetings as a Quality management representative including Area Management Team to ensure the effective running of the business
Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines
To perform additional tasks as agreed to support effective running of the business
Documentation, Training, CVS Governance, Supplier Management, QUMAS eDMS, TrackWise eQMS and LMS
Data bases for the quality system, metrics and quality trending reports, compilation and distribution of departmental monthly, quarterly and annual metrics
All documentation conforming to company, cGxP, regulatory regulations and guidelines. Check own work/documentation and that of others for accuracy. Site documentation archival and retrieval processes
Ensure that all customer requests are dealt with within a reasonable timeframe & provide assistance to customer with regard to license renewals.
What you need to apply:
Minimum of degree level in a science discipline with a post graduate qualification an advantage.
Minimum of 7 years working in the Pharma industry, some of which must be in a QA role in a manufacturing environment as well as 3 years people management & cross-functional project experience, including team coaching and development and leading strategic changes.
It would be an advantage if you are eligible to act as a Qualified Person under the permanent provision (2001/83/EC).
Qualifications/experience in Lean Six Sigma, Change Execution Management and Technical Problem Solving are also desirable.
You have a strong compliance mind-set, expertise with cGMP guidelines relating to pharmaceutical manufacturing as well as working knowledge of EDMS (Electronic Document Management System) and ERP (Enterprise Resource Planning).
Lead auditor experience is an advantage along with Customer & Regulatory Inspection hosting, preparation and support experience.
