QA Lead

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 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.

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 lead 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
- Stand as the single point of accountability for quality management and oversight of QA related activities relating to technology transfer and/or development projects at PGS Melbourne.
- Quality approver for documentation, including, but not limited to: investigations / commitments, batch records, SOP’s, Validation Reports, Technical Transfer Reports, Change Requests, audit reports, risk assessments to support project.
- Support as QA approver regulatory documents reviews for purposes of new product submission, variation or Board of Health enquiries related to the project with close liaison with Site QA Compliance team.
- Participate and support as QA rep for activities around product development, laboratory related tasks such as but not limited to exhibit batches, manufacturing trials and process validation batches.
- Provide QA guidance on planning and execution of validation activities.
- Ensure that appropriate Quality systems are adhered to in project execution such that site operations meet or exceed the requirements.
- Develop necessary programs to understand and document Critical Quality Attributes for products, Critical Process Parameters for processes and Critical Attributes for equipment.

**Qualifications**:
Must-Have
- Bachelor’s Degree in a relevant field and 8+ years’ of experience within industry
- Good organizational, presentation, meeting facilitation, project/time management and technical writing skills.
- Collective experience in quality management, pharmaceuticals and/or regulated environments.
- Good understanding and knowledge of sterile process requirements and validation as applied to the pharmaceutical equipment and facilities.

Nice-to-Have
- Master’s degree and relevant pharmaceutical experience.
- Excellent written and verbal communication skills with the ability to interact with senior leadership and cross functional teams.
- Experience within a Laboratory or Production/Manufacturing environment is desirable.
- Strong Analytical and problem-solving abilities.

Work Location Assignment: On Premise

Quality Assurance and Control

LI-PFE