QA Specialist

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 Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Suggest improvements and conduct continuous improvement activities.

• Independently assess a wide range of Change Control activities to determine potential Quality and Operational Good Manufacturing Practices {also cGMP} impacts.

• Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.

• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.

• Provide Quality Review and oversight of site cGXP documentation related to the operation of a vaccine manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.

• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

• Review and approval of validation documents Process, cleaning & method validation.

• Develop annual product quality review plan.

• Review and approve masterbatch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Qualifications
Must-Have

• Bachelor's Degree

• 5+ years' experience

• Experience in Quality administered systems

• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards

• Relevant experience in inspections by internal or external BOH .

• Proactive approach and strong critical thinking skills

• Must be able to work in a team environment within own team and interdepartmental teams

• Excellent communication and interpersonal skills

• Must have Experience in production batch record review including AMPs

• Experience in Quality operations

• Working knowledge to manage DOC , batch disposition scheduling and production batch record review .

Nice-to-Have

• Master's degree and relevant pharmaceutical experience

• Experience in Drug Product operations

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener

• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure

Work Location Assignment: Hybrid
We will only accept applications from colleagues via the formal route within Workday. Please do not submit paper or e-mail applications.
In line with good development planning, colleagues should discuss their suitability and/or readiness for a vacancy with their line manager prior to application. Colleagues are required to inform their manager if they are invited to attend interview. Where a line manager is not able to support an application either for suitability, readiness or business reasons, and a colleague continues to make an application, it is possible that an offer may not be made or maybe withdrawn.
Applications not received by the closing date will only be accepted in exceptional circumstances and will require the support of your senior management team.
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
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!

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