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, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishment and execution of the validation project strategy for a given sector of validation (i.e. equipment, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.
Want more jobs like this?
Get Business Operations jobs in Springvale, Australia delivered to your inbox every week.
As a Lead, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Manage multiple projects according to the CPA agreed timings and outcomes.
- Organize, lead and facilitate effective meetings. Identify and delegate action items. Facilitate action items to completion. Identifying and resolve project issues.
- Lead a team of Validation Engineers/Associates. Mentor and provide leadership and development opportunities to team.
- Provide technical leadership regarding the development of validation strategies and validation master plans post projects
- Contribute to generation of user requirements for equipment, facilities and services.
- Ensure that appropriate systems are in place such that site operations meet or exceed the requirements.
- Develop of validation strategies, validation master plans and documentation for facilities, utilities and manufacturing equipment, packing lines, laboratory equipment and computer systems.
- Integrate qualification activities to Pfizer quality management systems.
- Develop necessary programs to understand and document Critical Quality Attributes for products, Critical Process Parameters for processes and Critical Attributes for equipment.
- Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines.
- Prepare and execute site internal audit program including completion of identified actions.
- Support regulatory audit program
- Develop, introduce and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards.
Qualifications
Must-Have
- Bachelor's Degree and 8+ years' of experience.
- People Management experience.
- Extensive experience talking/dealing with regulatory and third-party representatives.
- Good organizational, presentation, meeting facilitation, project/time management and technical writing skills.
Nice-to-Have
- Master's degree and relevant pharmaceutical experience.
- Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities.
- Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies.
- Strong Analytical and problem solving abilities.
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