Validation Projects Lead
Vor 5 Tagen
We're in relentless pursuit of breakthroughs that change patients' lives.
We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Transforming Delivery of high quality products
PGS - Manufacture the Future
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 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 that aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.
As a Lead, your breadth of knowledge on internal or external business challenges will help us improve our products, processes, and services.
Your guidance will help us meet objectives and prepare 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.
Identify and resolve project issues.
Lead a team of Validation Engineers/Associates.
Mentor and provide leadership and development opportunities to the team.
Provide technical leadership regarding the development of validation strategies and validation master plans post projects.
Contribute to the 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 validation strategies, validation master plans, and documentation for facilities, utilities, manufacturing equipment, packing lines, laboratory equipment, and computer systems.
Integrate qualification activities into 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 the site internal audit program including the completion of identified actions.
Support the 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.
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 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.
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 Recognition & rewards program 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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