QA Manager
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| Job Type | Permanent |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2914 |
| Job Views | 975 |
- Description
- Team Horizon currently has an exciting opening for a QA Manager to work at our client’s facility in Sligo. This is an exciting opportunity to join a fast paced start up environment, where you will be responsible for supporting the operation of the Quality Management System (QMS) and carrying out and managing quality related activities.
Why you should apply:
This is an opportunity to work with an established Irish owned Early Phase supply partner, who value patient safety and Quality above all else.
What you will bedoing:
Preparation, routing for approval and filing of Standard Operating Procedures (SOPs)
Preparation, routing for approval and filing of Change Control Requests (CCRs), Deviations and CAPA
Preparation and updating of training records and management of the Training Program
scheduling, conducting and reporting on internal audits.
Preparation and submission of Manufacturing and Importation Authorisation (MIA) variations
Managing and ensuring follow up to risk assessments.
Managing quality control / assurance activities at
goods receipt,
incoming inspection,
transfer to inventory and / or quarantine
production operations
product approval and release
Ensure that the principles of Good Manufacturing Practice (GMP) are understood and followed.
Ensure that correct gowning and personnel hygiene procedures are followed at all times.
Ensure that all documentation is completed correctly in a clear and legible manner as required in accordance with ALCOA+ principles.
Follow the requirements of Standard Operating Procedures (SOP’s)
Follow and complete assigned training programs.
Be familiar with and ensure that Health & Safety requirements are complied with.
Preparation of User Requirement Specifications (URS)
Ensure compilation of equipment and facility documentation including operational, technical as well as maintenance instructions and information.
Conducting Risk Analyses (RA) on new equipment, facility or processes
Managing the execution of Installation Qualification (IQ), Operational Qualification (OQ and Performance Qualification (PQ) protocols.
Ensuring the compilation of qualification / validation summary reports
Assisting in resolution of any deviations that arise during qualification / validation activities.
Periodic (annual) review and issue of the Validation Master Plan (Schedule).
Provision of general project management support for the site.
Ensure that the senior management team is kept abreast of progress during qualification / validation activities and any deviations that may arise.
Manage the Quality Management System.
Influence and lead a small team of quality, validation and project professionals.
Act as a coach with clients and ensure support to clients at all times.
What you need to apply:
Degree in Science/Engineering/Quality.
Experienced in day-to-day operations in a highly regulated GMP manufacturing environment.
Management experience or an increased level of responsibility in quality roles.
Strong QMS experience.
Experience influencing and leading teams.
Client-facing experience.
