Quality 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 operations quality team. You will evaluate and review Pfizer’s clinical batches of drugs. You will make sure that product and process documents match the specifications based on established process control procedures. Your expertise will help in identifying deviations from established standards, in the packaging of products for clinical trials. In the relevant cases you will participant, review and/or approve investigations and change control activities to ensure compliance with configuration management policies. In the Quality Specialist role, 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:

• Align clinical study documentation to packaging product order output.
• Review and approve master batch records and executed batch records to assure compliance with procedural standards.
• Review and approve Clinical label content, including variable data approval.
• Render quality disposition of packaged supplies and supporting materials (e.g. labels, packaging component, comparator etc.) in current inventory system.
• Support Period of use / Expiry update of products.
• Independently solve error or issues presented during daily operations.
• Independently record verification checks performed in GMP documentation.
• 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.
• Investigate, document Quality Assurance related deviations, investigation 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.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Review, support and/or approval of validation documents, cleaning & method validation.
• Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.

Qualifications Must-Have

• Educated to Degree level
• Demonstrable experience
• Experience in Quality systems
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• 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
• Good working knowledge of Microsoft Excel and Word

Nice-to-Have

• Degree or Master's degree and relevant pharmaceutical experience
• 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: Flexible 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. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! 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 Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Quality Assurance and Control #LI-PFE