Manufacturing QA Chemist SME

Full Job Description

The closing date of applications is March 7, 2024.

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, or compliance your contribution will directly impact patients.

The Manufacturing QA Chemist Subject Matter Expert (SME) is a key role in the Quality Assurance team and is accountable as an experienced and strong technical leader, providing coaching for the wider Plant QA and C/O QA team(s), providing expertise for campaign start-up, execution, and change-over and leading key site initiatives relevant to the team.

What You Will Achieve

Through collaboration with all the site functions and site external stakeholders and customers, the Manufacturing QA SME, reporting to the Quality Assurance Team Leader and as a key member of the QA Team, is responsible for:

• Coaching of the Plant QA Team on the one best way approach to the Plant QA Chemist role including a focus on campaign start-up, change control, Intermediate and API batch releases, review and approval of Operating Instructions and review and approval of Deviations (QARs and Events), material re-evaluation, aligned with site Good Manufacturing Practices (GMP)
• Coaching of the C/O QA Team on the one best way approach to the C/O QA Chemist role with a focus on on-time execution of change-over, change control, review and approval of Post Manufacturing Instructions and review and approval of Deviations (QARs and Events) aligned with site Good Manufacturing Practices (GMP) and leading quality compliance for cleaning, continuous improvement and supporting Site performance goals.Coaching of the Plant QA and C/O QA Teams of the applicability of Standard Operating Procedures (SOPs), Pfizer Quality Standards (PQS) to day-to-day decision-making processes in the Plant QA and C/O QA Chemist roles
• Heighten awareness of Good Manufacturing Practices within the Plant PCT by leading by example and embodying GMP and SQE principles
• Supporting Plant QA and C/O QA Chemists and the Quality Assurance teams for optimization of their daily tasks adherence to the fundamentals of safety, quality, cost & supply and the importance of following the site 11 SQE principles in how they execute/approach their work
• Project management on key identified business initiatives and IMEx systems and processes where required.
• Supporting site performance, on time execution

How You Will Achieve It

The Manufcaturing QA Chemist SME, having direct responsibility for providing coaching, guidance, and expertise in GMP Quality compliance and supporting site performance goals will:

• Dedicated mentor to all Plant QA and C/O QA Chemist new starts within the SME’s local Plant PCT
• Support SOJT modules to accelerate effectiveness of Plant QA and C/O QA Chemist new starts.
• Use and coach on the application of site Standard Operating Procedures (SOPs), Pfizer Quality Standards (PQS)
• Bring experience in all aspects of quality assurance tasks to support the growing capability across the team.
• Support the Quality Assurance team as Responsible Person or QA Approver for local Quality Assurance deviations.
• Support Plant PCT in assessment of validation criteria in accordance with site Standard SOPs, PQS and ICH Q7 guidance
• QATL delegate for material flow meetings and other T2 meetings as required (Intermediate and API board)
• Owner of QA release backlog metric for relevant production facility
• Peer approver for final releases of Intermediates and API for new starts

Qualifications

The ideal candidate should have:

• Hold a B.Sc. and/or M.Sc./Ph.D. in relevant field e.g., Pharmacy, Chemistry, Science etc.
• Minimum 5 years relevant experience in the pharmaceutical or similar industries or related experience is advantageous.
• Proven track record in quality assurance for API manufacturing
• Demonstrates strong coaching ability with a willingness to both teach and learn from their peers and others.
• Show fresh, insightful thinking by developing creative approaches to processes and practices, products and solutions, services, business models and strategies.
• Demonstrated strong quality insight and Business Acumen by anticipating and knowing current and possible future policies, practices, trends, and information affecting his/her business and organisation.
• Excellent interpersonal skill and a strong ability to build relationships internally and externally.
• Demonstrates ability to work independently, informed decision making, ability to work across functions & cultivating effective team performance, influencing, empowering, collaboration, strong organisational & planning skills, communication skills.
• Knowledge of GMP regulations and PQS

 
Work Location Assignment: Flexible