Senior QA Associate

Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:

• Combine site inspection management and internal audit activities in a developing corporate network setting requiring a limited amount of travel.
• Administrate and coordinate the inspection readiness program for regulatory inspections aligned with company objectives and oversee the execution of inspection activities and timely management of regulatory stream activities through to commitment implementation.
• Manage external (regulatory and corporate) audits and assure Company practices meet TGA, PIC/S GMP, FDA, MHRA, EMA, Health Canada, cGMP and other regulations.
• As member of a developing corporate internal auditor group, perform internal audits at the site as participant and internal audits at other IMOQ sites as Lead auditor.
• Partner with key stakeholders to provide direction and guidance on GMP Compliance matters
• Administrate the Site Quality Review Team (SQRT) and Ad-Hoc SQRT
• Drive a proactive quality culture across the Company to deliver products Right First Time (RFT).

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Scientific or related discipline with 5 years experience or 3 of 5 years in a Quality function.
• Demonstrated experience working in a cGMP (current Good Manufacturing Practices) environment with strong understanding of Quality Systems functions
• Experience in preparing and participating in audits and inspections
• Self-motivated with a proven ability to deliver results in a team environment
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office and Date Analytic Tools
• Ability to travel

Bonus Points If You Have (Preferred Requirements)

• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues

Work Location Assignment: Hybrid
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Quality Assurance and Control
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