Description:
The Quality Systems Lead is responsible for ensuring that systems and products manufactured in the Dublin Compounding Facility comply with the Manufacturing Authorization, Good Manufacturing Practice (GMP), Irish and European Legislation and Baxter Healthcare Ltd Standards.
This role will have a lot of visibility and immediate impact with lots of possible opportunities.
They should provide quality assurance expertise and guidance in line with established company and regulatory standards
They will be responsible for the implementation and management of the Baxter Quality System within the Compounding Unit
The QS Lead must drive and support a culture of continuous improvement and standardisation within Baxter, whilst ensuring compliance with the Manufacturing license, customer requirements and Baxter requirements. Is responsible for the management of the release process, ensuring product meets specification and the customer order requirements prior to release and is released according to schedule.
To support and facilitate workforce engagement, utilising EMS, and staff development through objective setting and suitable development plans.
Essential Duties and Responsibilities
The Quality Systems Lead is accountable and responsible for the following activities:
Document and Data Management
- Ensures all procedures are controlled and current versions are available to staff as required
- Ensures there are no unauthorized changes to documents including creation of local documentation.
- Ensures all documentation is relevant and applicable to the process and is reviewed and updated.
- Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
- Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible
- Responsible for the review and approval of new and updated procedures, controlled documents and processes
- Drive and support standardisation across the EMEA Compounding Units.
Quality System Management and Review
- Responsible for the completion of the Quality Management Review meetings and the Annual Product Quality Review
- Ensure outcomes, decisions and actions of the review are documented
- Ensure meeting actions are completed to agreed deadlines
- Report monthly quality KPI to UK/Ireland QA Manager.
- Review of quality documentation. QA data review and compilation of reports
- Ensure systems are in place to track and trend quality system data and indicators, including but not limited to CAPA and Complaints. Trending should include timeliness in completion as well as actual numbers.
- Ensures appropriate Risk identification and management processes are implemented in the compounding unit
Audit Management
- Ensuring site-wide local systems are in compliance with Baxter Corporate and Regulatory requirements.
- Ensures the site has a process for internally reviewing the compliance status and is prepared for an audit at any time
- Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit
- Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
- Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue
Other Responsibilities and Duties:
- HPRA contact for the Manufacturing Licence and compounding issues
- Provide support to the site wide Quality Department
- Elements of your duties and responsibilities, in terms of routine activities, and specific projects, may span both Baxter Dublin Compounding operations. All such duties/responsibilities are governed by the overarching Baxter Quality Management System.
- Support compliance to Environmental Health & Safety (EHS) requirements
- Maintenance of professional status and standards
- Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
- Compliance to Environmental Health & Safety (EHS) requirements
EDUCATION AND/OR EXPERIENCE
- Bachelor's degree in Chemistry, Biology or a related scientific discipline.
- A minimum of 3 years working within quality in the pharmaceutical industry.
- Experience in dealing with Regulatory Compliance desired.
- Experience of the following would be beneficial:
- Leading Teams
- Risk Management
- Lean manufacturing experience
- Experience of implementing changes and process development
- Computer skills: MS Office, Excel, Visio and Track wise Quality management software would be advantageous