Senior Associate Quality Assurance (P)

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.
What You Will Achieve
In this Senior Associate Quality Assurance role, you'll be part of the Pharmaceutical Sciences Small Molecule Operations Quality team supporting Pfizer's newest clinical Active Pharmaceutical Ingredient (API) manufacturing facility in Ringaskiddy, Ireland. This role is an exciting and integral part of bringing new medicines to patients.
The primary responsibilities of this position are associated with the quality oversight of manufacture and testing for GMP clinical API, including:

• Disposition of product, intermediates, and ingoing materials
• Review of executed manufacturing batch records
• Contributing to manufacturing and laboratory quality investigations
• Using risk-management tools to assess quality issues occurring during API manufacturing and testing
• Contributing to Standard Operating Procedure development and compliance
• GMP Documentation Management

In addition, a colleague in this role will participate in the implementation of new initiatives, projects, and goals within Operations Quality and with business line partners (e.g. manufacturing, testing, etc.), to drive consistency, efficiency, and compliance.
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. The successful candidate will also possess sufficient knowledge of Current Good Manufacturing Practices and understand related scientific principles.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Business travel to other Pfizer locations and/or contractors/suppliers used by Pfizer may infrequently be required. This position does not include the management of direct reports.
How you will achieve it

• Review and approve executed clinical API manufacturing batch records to assure compliance with procedures, internal and regulatory standards.
• Perform disposition of clinical API, API intermediates, starting/raw materials, and reagents in support of API Manufacturing operations.
• Investigate and document manufacturing/testing deviations and escalate issues as appropriate to the Quality Operations Team Lead in a timely manner.
• Use risk-management tools to assess quality issues occurring during manufacturing/testing activities.
• Provide support to Inspection Readiness efforts, internal audits and regulatory inspections as needed.
• Contribute to the development and compliance of quality and business line partner procedures.
• Oversee GMP document management for the facility including management of the on-site library and off-site archival of paper records.
• Manage own time to meet agreed targets and develop plans for work activities on projects within assigned teams.
• Suggest improvements and conduct continuous improvement activities.

Must haves

• Relevant work experience in GMP manufacturing, testing, and/or quality assurance environment.
• Experience in handling GMP compliance issues and investigations.
• Must hold a degree and 3 or more years of relevant experience in technical/scientific/pharmaceutical experience/engineering or related.
• Knowledge of Current Good Manufacturing Practices (GMP) and applicable regulations and standards for pharmaceuticals.
• Knowledge of scientific principles (API-related experience preferred).
• Proactive approach with strong critical thinking skills and risk-based decision-making skills.
• Strong interpersonal skills and the ability to work effectively in departmental and cross-functional teams.
• Excellent collaboration and written and oral communication skills.
• High proficiency in MS Office applications and a demonstrated aptitude for computerized systems.

Nice to Haves

• Degree in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience.
• Previous Quality Assurance/Quality Systems experience
• Proficiency in computer systems, such as those supporting electronic document management, inventory management, investigations, LIMS, etc.
• Background in problem solving, data integrity principles, and project support in a matrixed reporting environment.
• Experience with Quality Risk Management.
• Experience with 6 Sigma and/or LEAN Continuous Improvement programs.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Work location: Flexible, On-site presence required a minimum of 2-3 days per week.
• Business travel (infrequent) may be required to other Pfizer locations and potentially to contractors /suppliers used by Pfizer.

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