Quality Operations Manager
3 weeks ago
Quality Operations Manager page is loaded Quality Operations Manager Bewerben locations Ireland - Dublin - Ringsend time type Vollzeit posted on Vor 3 Tagen ausgeschrieben job requisition id 4907786
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.
Additional Information
In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position
How to apply
Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you
Purpose
Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Quality Assurance and Control#LI-PFE About Us #J-18808-Ljbffr-
Senior Manager, Quality Operations, Global API
4 weeks ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Operations Data Quality Analyst
2 weeks ago
Dublin, Ireland Viatris Company Full timeOperations Data Quality Analyst page is loaded Operations Data Quality Analyst Apply locations Northern Cross, Dublin, Ireland Poland Remote Office United Kingdom Remote Office time type Full time posted on Posted Yesterday job requisition id R5644484 BGP Products Operations GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act...
-
Quality Manager
5 days ago
Dublin, Dublin City, Ireland GrabJobs Full timeWe are searching for an experienced Quality Manager to join our all-star team at North Cork Creameries in Cork.Growing your career as a Full Time Quality Manager is an incredible opportunity to develop competitive skills.If you are strong in persuasion, teamwork and have the right experience for the job, then apply for the position of Quality Manager at...
-
Operations Data Quality Analyst
2 weeks ago
Dublin, Ireland Viatris Inc. Full timeOperations Data Quality Analyst page is loaded Operations Data Quality Analyst Solicitar locations Northern Cross, Dublin, Ireland Poland Remote Office United Kingdom Remote Office time type Tiempo completo posted on Publicado ayer job requisition id R5644484 BGP Products Operations GmbH En VIATRIS, vemos la atención médica no como es, sino como debe...
-
Operations Data Quality Analyst
2 weeks ago
Dublin, Dublin City, Ireland Viatris Inc. Full timeOperations Data Quality Analyst page is loaded Operations Data Quality Analyst Solicitar locations Northern Cross, Dublin, Ireland Poland Remote Office United Kingdom Remote Office time type Tiempo completo posted on Publicado hace 2 días job requisition id R BGP Products Operations GmbH En VIATRIS, vemos la atención médica no como es, sino como debe...
-
Manager, Quality Engineering
3 weeks ago
Dublin, Dublin City, Ireland Edwards Lifesciences Full timeThe primary purpose of this job is to act as the communication cord between the manager and the employees. Oversees quality system metrics and data providing work direction for Quality Engineers and Quality Technicians to support and maintain quality management system, risk management and quality control plans. Responsible and directs activities for one or...
-
Manager, Quality Services
4 weeks ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Manager, Quality Services
4 weeks ago
Dublin, Ireland Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Operations Manager
3 weeks ago
Dublin, Ireland Elis Ireland Full timeWho are we?Elis is an international textile, hygiene & facilities services business, operating in 29 countries across the globe, delivering a complete textile rental and laundry service. We offer everything from workwear to mats, mops, bed and bath linen, hygiene supplies and pest control services.With plants and distribution hubs across Ireland, Elis offers...
-
Quality Engineer
3 weeks ago
Dublin, Dublin City, Ireland Stryker Corporation Full timeProvide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our...
-
Quality Auditor
7 days ago
Dublin, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 5+ years City Dublin State/Province Dublin Country Ireland Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US,...
-
Quality Auditor
2 weeks ago
Dublin, Ireland PSC Biotech Ltd Full timeAbout PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Quality Technician
2 weeks ago
Dublin, Dublin City, Ireland Cpl Full timeOn behalf of our client, we currently have an excellent opportunity for a Quality Technician to join a growing Medical Technology company. Dublin location, predominately site based with some hybrid.The Quality Technician will work closely with colleagues to support the following activities:· Creation, review, and approval of QMS documentation.· Process and...
-
Spa Operations Manager
3 weeks ago
Dublin, Ireland Autograph Collection Hotels Full timeJOB SUMMARY Position has responsibility for supervising and coordinating activities of employees delivering spa services, including salon, skin care, program coordination, reservations, reception desk, massage and locker room areas. Position focuses on ensuring guest and employee satisfaction and achieving the operating budget. CANDIDATE PROFILE Education...
-
Dublin, Ireland Amazon Ireland Support Services Limited - A94 Full timeAt Amazon, we're working to be the most Customer-centric company on earth. One customer experience that we’re constantly looking to take to a new level is how we fulfill and deliver their orders. Our goal is to exceed the expectations of all our customers by ensuring that their orders, no matter how large or small are delivered where and when they need...
-
Global Leakage Manager
3 weeks ago
Dublin, Ireland ALLIANZ PARTNERS Full timeWhat you do The Operations Leakage Manager is placed within our Quality division in Operations and is directly reporting to the Central quality Lead. The role is responsible for identifying, investigating, and mitigating operational leakage. Leveraging data analytics and strong understanding of operational processes together with underwriting...
-
Evening Operations Manager
3 weeks ago
Dublin, Ireland Voltedge Full timeWe have a fantastic opportunity for an experienced individual to join our client's team as Evening Operations Manager. Position: Evening Operations Manager Location : Dublin, Republic of Ireland Industry : Accommodation Services Working Hours : 10:00 pm to 8:00 am Hourly Rate : €17 per hour Key Responsibilities: ·Oversee security measures...
-
Spa Operations Manager
3 weeks ago
Dublin, Ireland Marriott International, Inc. Full timeJob Number 24054377 Job Category Spa Location The Shelbourne Autograph Collection, 27 St. Stephen's Green, Dublin, Dublin, Ireland VIEW ON MAP Schedule Full-Time Located Remotely? N Relocation? N Position Type Management JOB SUMMARY Position has responsibility for supervising and coordinating activities of employees delivering spa...
-
Operations Manager
3 weeks ago
Dublin, Ireland Navro Full timeDublin, Ireland / Compliance / Full Time Join our fast-growing FinTech startup as Compliance Analyst! We're looking for a driven individual to join our dynamic and growing team. At Navro, we value diversity and are committed to creating an environment where everyone feels supported and empowered to contribute their unique perspectives. Join our...
-
Operations Manager
4 days ago
Dublin, Ireland Broadline Recruitment Group Ltd. Full timeOur well-known client based in Dublin 15 are currently working with us to source their new Operations Manager. This is an exciting role well suited to an ambitious professional looking for a new challenge and being part of a hardworking and collaborate team. Our client can offer career development and progression with many of their team members excelling in...