Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.
What You Will Achieve
In this role, you will:
- Lead and co-lead moderately complex projects, effectively managing time and resources.
- Make quality decisions to resolve moderately complex issues with minimal assistance from management.
- Leverage UK Time Zone, to effectively manage global workload across Groton, Sandwich and Chennai.
- Quality Assurance Subject Matter Expert (SME) in the Global Material Review Process (GMRP).
- Apply skills and discipline knowledge to contribute to departmental work and decision-making.
- Resolve moderately complex problems and develop new options, guided by policies in non-standard situations.
- Work independently on assignments, seeking guidance on unusual or complex problems.
- Review your own work and mentor colleagues by reviewing their work and providing guidance when needed.
- Perform quality assurance disposition function for excipients, packaging components, cleaning agents, and processing aides.
- Review and approve excipients and packaging specifications (i.e., LPS and PCS) to ensure compliance with Compendia and Pfizer specific needs.
- Utilize judgment and experience to become a resource for others and lead quality risk management efforts.
- Provide Quality support for GMM materials used in the Ringaskiddy RCMF Facility to meet the needs of manufacturing.
- Support audit teams when needed (global/ onsite).
- Ability to globally train/mentor colleagues (i.e., Groton, Sandwich and Chennai) in the areas of material disposition and GMRP.
- Provide Global Quality support for Change Management with expertise in supporting atypical business challenges.
- Review and/or approve various GMP documents, investigations, procedures, change controls, and CAPAs.
- Demonstrate strong interpersonal, teamwork, and collaboration skills.
- Participate on special projects, limited duration teams, and global initiatives such as continuous improvement teams for Quality Assurance.
- Recognize when an issue is beyond their sphere of influence and escalate immediately.
- Evaluate applicable corrective and preventive action responses to investigations and audit findings for adequacy and timeliness.
- Author, reviewer and approver of both global and local procedures.
Here Is What You Need (Minimum Requirements)
- BA/BS with some relevant experience or associate's degree (or UK equivalent) with strong relevant experience or high School Diploma (or Equivalent) with extensive relevant experience
- Knowledge of training design and tools and experience in applying training methodology
- Experience operating in the following systems: EMD365, eQMS Change Management and Deviation modules, GDMS, Clementine, SMS, LPS, and QTS Commitment Tracking.
- Solid understanding of cGMP, Data Integrity, and ALCOA principles.
- Exceptional organizational and project management skills
- A solid understanding of the regulatory and audit frameworks pertinent to pharmaceutical operations
- Capable of managing multiple complex projects with a strong sense of business acumen
- Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills
Bonus Points If You Have (Preferred Requirements):
- Experience in quality control and/or quality assurance within the pharmaceutical industry
- Experience in inventory management and operational knowledge
- Ability to adapt to changing priorities and manage multiple tasks simultaneously
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: Hybrid
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