Senior Associate Quality Operations

**Job Profile**
Location: Colleague will be based in Sandwich, Kent, UK

The Quality Operations position will support the Global PSQA Pharm-Sci Small Molecules QO department by performing Quality Assurance activities associated with the manufacture and testing of GMP.

Clinical Drug Product, Solid Dose Manufacturing (SDM), including disposition of product and materials, investigations, change control, SOPs, Validation and ensuring adherence to regulatory and internal compliance standards.

**Organisation Relationships**
This role is within the global Pharmaceutical Sciences QA group. Primary relationships with quality assurance team and the Pfizer business lines supported (i.e. Drug Product Supply). Primary relationships with product team members (i.e. ARD, DPS) that you participate on. Relationships with vendors (CMO’s) and other Pfizer sites across the globe, as applicable.

**Role Profile**

This position requires an understanding of quality systems as they relate to the manufacturing, testing of Drug Product.

Minimal business travel may be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer.

This position does not include the management of direct reports.

**ROLE RESPONSIBILITIES**:

- Provide QA GMP guidance and support of Investigation Medicinal Product manufacture, testing and release for clinical use to the business line.
- Look to Identify quality continuous improvement efforts to streamline compliance and efficiencies in support of Sandwich DP Manufacturing operations.
- Provide support on GMP audits management programs and work to resolve audit observations as required.
- Build relationships with the business through early engagement and ongoing interaction / consultation with key personnel, including project teams.
- Complete job-related training and maintain personal training records
- Support quality oversight of the Pharm Sci equipment & cleaning validation system lifecycle activities
- Contribute to the development and compliance of quality and business line partner procedures

**Training and Education preferred**:
Bachelor’s Degree (B.S.), preference in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience.

Relevant work experience in a scientific/pharmaceutical environment preferred.

Must possess strong written and oral communication skills as well as strong computer skills.

Must exhibit strong interpersonal skills and the ability to work effectively in teams.

All applicants must have the relevant authorisation to live and work in the UK.

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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.

Quality Assurance and Control

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