QA Systems Associate ( 2 year fixed term)

Use Your Power for Purpose
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will have a direct impact on patient care. Your focus and commitment will be essential in achieving project tasks and goals, fostering a collaborative environment for your colleagues. Your hard work and dedication will help Pfizer reach new milestones and make a significant impact on patients worldwide.
What You Will Achieve
The primary purposes and key accountabilities of the QA Systems Associate at the PGS Melbourne site are:

• The administration of Change Control, Risk Management, and Documentation systems, and in particular:
  • The evaluation of the impact and risk presented by proposed changes to the Pharmaceutical Quality System
  • The review and approval of GxP documents, including procedures, operating instructions, master batch records, protocols, reports and logbooks
  • Support computerized systems deployment and maintenance as required
• The Quality support of changes, ranging from major site projects to relatively simple initiatives and adoption of global procedures.
• The preparation of Product Quality Review reports on the designated topic within the responsibility of Quality Systems
• Approving changes to product artwork, procedures and material master.

Where necessary, support quality investigations associated with the design or administration of Quality Systems
The essential responsibilities of the Quality Systems Associate are:

• To assure that company practices align with the Pfizer requirements and the codified rules adopted by the Australian Therapeutic Goods Administration (TGA), United States Food and Drug Administration (FDA), Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), Health Canada and other regulators
• Collaborate with colleagues to enable efficient progression of tasks and seek advice from management as needed to ensure risks are understood and decisions well-informed
• The timely completion of assigned work to support business needs
• Participate in tiered accountability huddles for the assignment of work and the determination of priorities
• Participate in the site's continuous improvement culture
• Adopt a mindset of continuous improvement initiatives in day to day work

Conduct self in accordance with Pfizer's code of conduct and company policies
Here Is What You Need (Minimum Requirements)

• Minimum Bachelor's Degree in an Engineering, Scientific or related discipline.
• Self motivated with excellent verbal, written, presentation and interpersonal communication skills.

Bonus Points If You Have (Preferred Requirements):

• Knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products
• Proven ability to plan, implement, and achieve goals and objectives.
• Demonstrable knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements for Australia, Europe, and the USA.

Work Location Assignment: On Premise
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.
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Quality Assurance and Control