Aseptic Specialist

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:

• Lead and deliver Aseptic Excellence and Sterility Assurance Programs, whilst interfacing with global support teams.
• Partner with key stakeholders to provide direction and guidance on GMP Compliance matters relating to sterility assurance and monitor aseptic operations and compliance status
• Lead or participate in investigations and implement corrective actions
• Review and approve reports, risk assessment, procedures associated with sterility assurance
• Prepare for and participate in Site Internal Audits, Corporate Audits and BOHs Inspections, ensuring successful outcomes and timely implementation/closure of action plans.
• Contribute to moderately complex projects, manage time effectively, and develop short-term work plans.
• Drive a proactive quality culture across the Company to deliver products Right First Time (RFT).

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• 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, Microsoft Project, and Statistical Software

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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