This Quality Operations position will support the Global PSQA PharmSci Small Molecules QO department by performing Quality Assurance activities associated with the manufacture and testing of GMP

clinical API, including disposition of product and ingoing materials, investigations, change control, SOPs and ensuring adherence to regulatory and internal compliance standards.

Location: Colleague will be based in Sandwich, UK.

ROLE SUMMARY

The candidate will partner with key business lines to provide QA GMP guidance and support of clinical API manufacturing and testing operations. As a member of PSSM QO lead the implementation of new initiatives and goals within PSQA, PSSM QO, and with business line partners (e.g. manufacturing, testing, etc.), to drive consistency, efficiency and compliance.

This position requires an understanding of quality systems as they relate to the manufacturing and testing of API.

The candidate should possess sufficient knowledge of cGMPs, and Pfizer quality processes and procedures for specific quality tasks and have a knowledge of scientific principles.

Business travel will 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

• Perform disposition of clinical API, API intermediates, starting materials, raw materials, reagents in support of Sandwich and external API Manufacturing operations.
• Provide QA guidance and support to new initiatives and technologies within QA and with PSSM QO business line partners (e.g. API Manufacturing, GMP Analytics, ARD).
• Provide sound QA guidance to investigations of product/facility deviations.
• Use risk-management tools to assess quality issues occurring during manufacturing/testing activities.
• Contribute to the development and compliance of quality and business line partner procedures.
• Provide support to Inspection Readiness efforts, internal audits and regulatory inspections as needed.

• Effectively collaborate with functional leadership to ensure local processes and quality systems are in alignment with global initiatives and standards.
• Continuously assess performance within area of responsibility against the Quality System Elements
• Identify opportunities and facilitate improvement solutions to ensure consistency, compliance and best practice sharing.

Training and Education preferred:

Relevant work experience in GMP API manufacturing, testing and/or QA environment. Experience with handling GMP compliance issues and investigations. Proficiency in computer systems, such as those supporting electronic document management, inventory management, investigations, LIMS, etc. Experience in leading cross-functional teams.

Bachelor's Degree (B.S.), preference in Industrial Pharmacy, Pharmaceutical Science, Chemistry, Engineering, or Biology, or equivalent experience. Prior Experience preferred.

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.