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QA Lead

2 weeks ago

Mulgrave, Australia Pfizer Full time

Pfizer’s purpose 'Breakthroughs that change patients’ lives’ fuels everything we do. We innovate every day to help make the world a healthier place. From scientific discovery to breakthrough products to our essential partnerships around the world, we’re committed to quality healthcare for everyone. Because every individual matters.

What You Will Achieve

You will achieve a strong QA presence for the end-to-end Quality process of new product introduction and provide sound quality decisions to support manufacturing process, validation and regulatory submissions.

How You Will Achieve It
- Act as Quality Lead for projects relating to new product introduction, ensuring support on quality issues/notifications, concerns and communications. This includes (at a minimum) notification for: investigations, change requests, audits, AQPRs
- Act as the Quality representative for site projects such as the introduction of new technologies, as required
- Ensure activities and operations are compliant with GMP and legislation as directed by Australian code of GMP, other equivalent international Acts and customer requirements
- Support plant audits, drafting plant responses and managing the closure of commitments to agreed timeframes
- Act as QA core team member for technology transfer, developmental projects and cGMP matters
- Liaise with relevant QA and QC teams on quality related activities in accordance to procedures to meet business needs and agreed targets
- Support the Quality group in relation to (but not limited to) investigations/commitments, change requests, audits, APQRs, validation ensuring these are addressed per business requirements and targets
- Act as Quality Approver for GxP and validation documentation, deviations and CAPA related records, and other quality documentation
- Act as a stand in for the QA Projects and Technical Support Manager, as required

Must Have
- Demonstrable knowledge of cGMP and Regulatory requirements for Australia, EMEA and USA.
- Strong knowledge of Quality Systems, and decision making in a compliance environment
- Excellent leadership and communication skills
- Excellent problem-solving skills and strong customer focus
- Bachelor of Science or related discipline. Business Degree or Post Graduate degree an advantage
- 5+ years' experience in quality management, pharmaceuticals and/or regulated environments. Experience within a Laboratory or Production/Manufacturing environment is desirable
- Knowledge and understanding of the technical, regulatory and commercial aspects of pharmaceutical products
- Global pharmaceutical management experience including interaction with management and regulatory agencies, and managing relationships with global regulatory bodies (i.e. TGA, FDA MHRA, PMDA,)
- Demonstrated ability to interpret and implement requirements of GMP regulations
- Proven ability to plan, implement, and achieve complex goals to Global Quality Standards and objectives, and ability to manage/co-ordinate service/project delivery across functional groups
- Possess excellent verbal, written, presentation and interpersonal communication skills.
- Must be capable of multi
- tasking job tasks through multiple customer and plant processes.
- Sound knowledge of computer packages eg Microsoft office package, such as MS Powerpoint, Word, Excel, Access and Project.

Work Location Assignment: On Premise

Quality Assurance and Control

LI-PFE