Responsible for managing validation projects, ensuring compliance with standards, supporting engineering activities, performing statistical analysis, and maintaining quality systems.
Role Summary
In your role, you will be responsible for supporting the planning, managing, performing, and reporting of validation projects for the site (e.g., equipment, computer system validation, continued process verification, process, cleaning, etc.). Ensuring smooth integration from qualification to requalification is a key outcome of this position. As a Senior Associate, your knowledge of internal or external business challenges will help us improve our products, processes, and services. The application of a continuous improvement mindset will help us advance new concepts and methodologies. Additionally, you will provide technical support and assist in problem-solving.
Role Responsibilities
As a Senior Validation Associate, you will play an active role in the site validation strategy. You will:
Qualifications & Responsibilities
Work Location Assignment: On Premise
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
*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
#LI-PFE
In your role, you will be responsible for supporting the planning, managing, performing, and reporting of validation projects for the site (e.g., equipment, computer system validation, continued process verification, process, cleaning, etc.). Ensuring smooth integration from qualification to requalification is a key outcome of this position. As a Senior Associate, your knowledge of internal or external business challenges will help us improve our products, processes, and services. The application of a continuous improvement mindset will help us advance new concepts and methodologies. Additionally, you will provide technical support and assist in problem-solving.
Role Responsibilities
As a Senior Validation Associate, you will play an active role in the site validation strategy. You will:
- Evaluate, review, and approve validation master plans, IQ/OQ/PQ protocols, and summary reports, ensuring compliance with company and industry standards and regulatory requirements.
- Provide support to engineering for any validation related activities include FAT and SAT.
- Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
- Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
- Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
- Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
- Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
Qualifications & Responsibilities
- Bachelor's Degree with minimum 5+ years' experience.
- Proven expertise in Good Manufacturing Practices.
- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
- Strong working knowledge of various quality systems and processes.
- Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.
- Excellent verbal and written communication skills.
- Strong organizational and time management skills.
- Ability to mentor and guide other colleagues.
- Experience with sterile products and medical devices.
- Experience in regulatory audits and compliance
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.
Quality Assurance and Control
#LI-PFE
Top Skills
Global Document Management System
Good Manufacturing Practices
Quality Tracking System
System Application & Products
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