Operations Quality Manager
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| Job Type | Permanent |
| Location | Dublin |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | #1002613 |
| Job Views | 1048 |
- Description
- Operations Quality Manager – Team Horizon
We are seeking applications for an experienced Quality Manager to join our client’s pharmaceutical sites in Dublin, if you are excited by the challenges that come from working in a large operation and are passionate about delivering high-quality project execution, strengthening service model for customers and patients, while improving total delivered profit. A new role, managing across the two sites has been created to ensure that robust systems and processes are in place and that product release can occur, ensuring all products are fit for purpose and patient safety is assured.
In this role you will be responsible for ensuring that the sites comply with the principles of Good Manufacturing Practice (GMP), European Legislation and client standards, that adequate and suitable Quality Systems are in place, that the Quality System functions effectively and to support the QP (or delegates) in the release of products from the Dublin Compounding Organization in accordance with the requirements of the Manufacturing Authorization.
Why you should apply:
This is a challenging opportunity and a chance to work in a diverse team with a great mix of people.
Employees are encouraged to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers.
You are ambitious and desire a career with an innovative forward-thinking company.
What you will be doing:
Ensuring that a suitable Quality Management System is established, implemented, and maintained, where applicable.
To ensure that processes and procedures are complying to the Corporate Quality Manual and client internal policies, procedures and practices.
To ensure regulatory compliance to the applicable regulations in line with the Irish Healthcare Products Regulatory Agency (HPRA), guidance and European requirements as applicable.
Ensure that a robust process for the review and release of product exists and is implemented.
Act as Management Representative for the Dublin sites to include:
Performance of the QMS and any need for improvement is reported and actioned upon.
Promotion of awareness of best practice and champion continuous improvement throughout the Dublin Units.
Ensure compliance to Good Manufacturing Practice for Medicinal Products for Human Use (Eudralex Volume 4 of "The rules governing medicinal products in the European Union") in accordance with Commission Directive 2003/94/EEC and applicable amendments.
Support the batch release teams and Qualified Persons to discharge their duties in relation to batch release and the conditions of the license.
To act as the key contact within the Country and Cluster business with, for example, HPRA and MoH, Senior Leadership and Quality Management with relation to quality, efficacy and general GMP matters, as point of contact for any Field Alerts or Recalls and for communications with other client functions, as applicable (i.e. Regulatory Affairs, Vigilance, Pharmacovigilance, Medical Affairs, Warehouse & Distribution).
The Operations Quality Manager is accountable and responsible for the following activities
Management of local quality personnel and day to day activities.
Ensure that adequate resource is in place to manage all Quality Systems and support batch release processes.
Provide support to the site wide Quality Department, including coaching and mentoring of junior staff and high potential individuals.
Training of Quality and Compounding Unit staff.
Develop a culture of continuous quality improvement within the client.
Ensuring site-wide local systems are in compliance with the client and Regulatory requirements.
Participation in regulatory and corporate/internal audits and performance of supplier audits (as required).
Review and approval of process Change Controls, Standard Operating Procedures (SOPs), Validation Protocols and Reports.
Report to the Head of Quality for UK, Ireland and Nordics and escalate issues in a timely manner.
Act as HPRA contact for the Manufacturing Licence and compounding issues.
Evaluation of new products & processes.
Development of quality system procedures, controlled documents and processes.
Risk Management of the quality system and processes.
Liaise with local Qualified Persons (QP) on the supervision of the Quality (Deputy) Batch Releaser teams to ensure that products manufactured as per EU Directives, Manufacturing Authorization and EU GMP.
Ensure products and processes comply with procedures and the principles of GMP.
Management of the Compounding Unit Quality System including CAPA Events, change control and external and internal audit closure.
Maintaining awareness of Quality Management Review and Annual Product Quality Review reports, relevant deviations, CAPAs, change controls, Regulatory Authority Inspections and Product Complaints and the use of unlicensed drug components.
Review of quality documentation, QA data review and compilation of reports.
Assessment of the need for and implementation and management of (if required) Recalls and Field Alerts.
Review and investigation of non-conformances/CAPA Events and reject/scrap reports and implementation of corrective and preventative actions.
Coordination, performance, and approval of corrective and preventive action investigations.
Performance and supervision of complaint and quality defect investigations and recall assessment (as above).
Reporting of Adverse Events for Pharmacovigilance assessment.
Overview of regulatory/guidance and legislative updates relevant to the client.
Support facility projects including process development and quality improvement initiatives.
Maintenance of professional status and standards.
Compliance to Environmental Health & Safety (EHS) requirements.
What you need to apply:
Degree in pharmacy or a science-related discipline.
Experience as a Quality Manager in an aseptic processing or sterile manufacturing site.
Experience communicating with Regulatory Authorities and Senior Management.
Regulatory Audit experience.
