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 directly impact patients.
What You Will Achieve
You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's 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. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Manager , 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 products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your problem solving skills 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 manufactured in accordance with the MA, and with Good Manufacturing Practice (GMP).

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

• The batch and its manufacture comply with the provisions of the Manufacturing Licence.

• Manufacture has been carried out in accordance with current Good Manufacturing Practice.

• The principal manufacturing and testing processes have been validated where appropriate ; 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 responsible in accordance with a defined system.

• All the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because 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 of appropriate Pfizer Global Standards and Quality Systems.

• To regularly interact with appropriate team members in all functional groups associated with batch manufacture and testing, forging strong team relationships across diverse functions.

How You Will Achieve It

• Provide guidance, lead/co-lead projects, manage own time to meet objectives , 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, as appropriate .

• 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.

• Ensure appropriate networking and 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.

• Ensure appropriate internal networking to develop and maintain close and effective business partner relationship with internal colleagues.

Qualifications
Must-Have

• Bachelor's 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 System Trackwise , Documentum platforms

Nice-to-Have

• Master's 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
Work Location Assignment: Hybrid
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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Quality Assurance and Control