Qualified Person

Job Description

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 directlyimpactpatients.

What You Will Achieve

You will be a member of Pfizers dedicated and highly effective quality assurance team. You will evaluate and review Pfizers clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Yourexpertisewill help inidentifyingdeviations from established standards in the manufacturing and packaging of the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As aManager you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for productsprocessesor services. Through your comprehensive knowledge of principlesconceptsand theories of the discipline you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role tofacilitateagreements between different teams.

It is yourproblem solvingskills that will make Pfizer ready to achieve new milestones and help patients across the globe.

Role: Qualified Person

• Assure compliance to with the conditions of the Marketing Authorization (MA) by certifying that a product has been manufacturedin accordance withthe MA and with Good Manufacturing Practice (GMP).

• Be responsible forensuring that product is released as per directive 2001/83/EC as amended by 2004/27/EC.

• The batch and its manufacturecomply withthe provisions of the Manufacturing Licence.

• Manufacture has been carried outin accordance withcurrent Good Manufacturing Practice.

• The principal manufacturing and testing processes have beenvalidatedwhereappropriate; account has been taken of the actual production conditions and manufacturing records.

• Any deviations or planned changes in production or quality control have been authorised by the persons responsiblein accordance witha defined system.

• All the necessary checks and tests have been performed including anyadditionalsampling inspectiontestsor checksinitiatedbecause of deviations or planned changes.

• All the necessary production and quality control documentation has been completed and endorsed by the staff authorized to do so.

• All audits have been carried out as required by the quality assurance system.

• Account has been taken of any other factors of which they are aware which are relevant to the quality of the batch.

• Maintain up to date knowledge ofappropriate PfizerGlobal Standards and Quality Systems.

• To regularly interact withappropriate teammembers in all functional groups associated with batch manufacture and testing forgingstrong teamrelationships across diverse functions.

How You Will Achieve It

• Provide guidance lead/co-lead projects manage own time to meetobjectives plan resource requirements for projects across the Department.

• Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.

• Assess the operations executed at the supplier for their adherence to regulatory requirements Quality Agreement requirements and Pfizer expectations.

• Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management Platform Lines and Regional Medical Quality group asappropriate.

• Support the development of country quality strategic initiatives based on risk and business needs in close collaboration with key stakeholders.

• Lead continuous inspection readiness for Quality Assurance.

• Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.

• Ensureappropriate networkingand sharing of best practices with Corporate Compliance colleagues and with other compliance functions in other Pfizer affiliates or in the market.

• Participate in internal Good Manufacturing Practices also cGMP audits and support regulatory inspections or corporate audit activities.

• Perform disposition of clinical trial materials.

• Communicate with and influence internal and external customers across site and department boundaries to ensure compliant and aligned resolution of project related issues and investigations.

• Ensureappropriate internalnetworking to develop andmaintainclose and effective business partner relationship with internal colleagues.

Qualifications

Must-Have

• Bachelors Degree QP qualified

• 5 years experience

• Pharmaceutical manufacturing/Quality experience

• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects regulations as related to vendor management programs and other industry quality systems and processes

• Proactive approach and strong critical thinking skills

• Strong collaboration relationship management and interpersonal skills

• Excellent written and verbal communication

• Advanced computer skills in MS Office applications and good knowledge of enterprise systems such as PDM Quality Tracking SystemTrackwise Documentum platforms

Nice-to-Have

• Masters degree

• Experience in Quality Systems in pharmaceutical medical device or combination product industry

• Knowledge or exposure to and data sciences

Work Location Assignment:On Premise

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!