Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The role of the Quality Operations Manager is to support the Quality Lead in establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations.
In addition, the QO Manager will act as delegate for the Quality Lead in the investigation and resolution of all product quality issues discovered or originating in the Pfizer Country Office (PCO) and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical) and Pfizer Global Supply (PGS) on such issues.
The QO Manager will assist the Quality Lead with the monitoring of product quality and compliance activities at the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections.
The QO Manager will also assume the role of Deputy Responsible Person on Pfizer Healthcare Ireland’s Wholesale Authorisation.
How You Will Achieve it:
1. Resolution of Product Quality Compliance Issues
Deviation Management:
- Investigate, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the country organization and agree and track preventive/corrective actions.
- Ensure that any deviations to GxP process are assessed and fully investigated and any associated CAPA are correctly tracked.
Product Complaint handling:
- Oversee the intake and triage of complaints from the local market.
- Ensure any suspect falsified medicine is investigated and reported.
Notification to Management
- Inform PCO key stake holders and PGS QO Management of significant deviations and complaints.
- Act as delegate for the Quality Lead at Quality review team meetings and plan local actions such as communication with Regulatory Authority, local corrective/preventive actions and market actions as required.
- Participate in Rapid Response Teams (RRT) in formulating communication packages for the Regulatory Authority.
2. Quality Management System
- Assist the Quality Lead with the maintenance of the Quality Management System,
- Manage a gap analysis process for the effectiveness of Global SOPs against PCO requirements. Ensuring all gaps are appropriately risk assessed and accounted for.
- Monitor key quality performance indicators, evaluate and highlight any significant trends and identify actions.
- Conduct internal assessments to assess compliance with quality management systems and processes, and to identify improvement opportunities.
3. Local Product Disposition
- Provide support to the team in the management of the local release of receipted products, in compliance with local procedures, prior to distribution/sale within Ireland.
- Conduct assessment of medicinal product returns that can be taken back to saleable stock and support local actions, in cooperation with logistics service provider (LSP).
4. Inspections and Internal Audit
- Support the preparation and coordination of Regulatory Authority and internal Pfizer inspections of Product Quality and Compliance (GMP/GDP) activities in Ireland.
- Work with local functions to define an appropriate action plan to address inspection/audit deficiencies.
- Track the implementation of the identified actions within agreed timeframes
- Conduct Self-Inspections/quality reviews of local functions and processes to ensure compliance with GMP/GDP activities.
5. Logistic Service Provider Oversight
- Assist with the quality oversight of the Logistics Service Provider (LSP), which includes but is not limited to:
- Deviation Management: evaluate the impact of all significant deviations affecting product quality, generated at the LSP and agree corrective actions.
- Quality System Support: visit the LSP to assess quality systems, review quality performance and agree action plans to ensure continuous improvement.
- Support the Quality Lead with the facilitation of the Pfizer corporate audit process at the LSP and assist in defining appropriate action plans for improvement and follow-up.
6. Business Support and Development
- Act as delegate for the Quality Lead as required in PCO critical business processes, e.g. LSP Management Reviews.
- Participate in business initiatives as required, giving advice and direction on effects to quality and compliance.
Qualifications
Must-Have:
- Life sciences degree.
- Extensive experience working for a Pharmaceutical Company in Quality Assurance (QA)/Quality Control (QC).
- In-depth knowledge and understanding of Quality systems, processes, audit and inspection.
- Excellent communication and interpersonal skills.
- Attention to detail.
- Continuous improvement orientation.
Nice-to-Have:
- Good in-depth knowledge and understanding of Irish and EU legislation, guidelines and procedures relating to GDP
- Eligible as a Deputy Responsible Person.
- Strong negotiation and effective communication skills.
- Excellent system skills – Word and Excel essential, experience with electronic documentation control systems.
Make a difference today! All suitable candidates should apply through the link with CV provided. We are looking forward to hearing from you!
In order to be considered for this position you need to be legally eligible to work in the EU.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Due to the high volume of applications we will be contacting successful candidates only.
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