QA Lead - Projects - Fixed Term

Summary about this job

Detail information about job QA Lead - Projects - Fixed Term. Terms and conditions vacancy

Pfizer Melbourne is currently looking for an enthusiastic and motivated candidate to work as a QA Lead for new technologies being introduced to the site based in Melbourne Victoria.

In support of the growth of the Pfizer Melbourne business for a number of new technologies including Medical Devices and Combination Products (drug delivery systems), nanoparticle technology, powder fills, and biological medicines, the QA Lead – Projects will be the primary quality contact responsible for establishing and managing the quality requirements of products to commercialisation, including managing personnel reporting to the role, site inspections and licence requirements.
 
Role Responsibilities:

QA Lead – Projects will be responsible for working closely with the teams to ensure all site requirements are communicated and that the products can successfully and compliantly be manufactured. Responsibilities include:
 

• Establishing, improving and maintaining a quality system to support the new technologies to meet appropriate regulatory and company requirements
• Quality oversight in the day to day activities
• Manage a small team providing quality support for the new technologies
• Lead/maintain accreditation for ISO 13485: 2016 (or equivalent) and compliance to TGA, PIC/s and US CFR requirements for these new technologies
• Lead audit preparations in-readiness for external inspections and internal audits against ISO: 14385, 21 CFR Part 820 [QSR]), PIC/s, 21 CFR 210/211 and prepare associated responses
• Lead associated quality management meetings with senior management across the business
• Oversee Investigations, Internal Audits, Annual Product Quality Reviews and Vendor Assurance, Complaints, Documentation & Change Controls for Combination products. Determine the impact of these events and escalate in accordance with Pfizer processes.
• Lead and support investigations of significant quality and/or regulatory events associated with external suppliers
• Identify quality continuous improvement efforts to streamline compliance and efficiencies

The Ideal Candidate

You will be flexible, self-motivated and have a 'can do' attitude. The successful candidate should ideally have proven experience of working in a similar role or in a cGMP flexible manufacturing environment, with excellent communication and writing skills. The role will be challenging and require someone dynamic with ability to work on multiple projects. You will be used to meeting challenging deadlines and improve performance through continuous improvement and use of business tools.

You must be able to think and problem solve in situations that require tight time frames. Independent action and sound decision making are essential for success in the position and required the ability to motivate key stakeholders and inputs to deliver quality outcomes to business requirements.
 
Key requirements of this role include experience in a compliance role within the pharmaceutical industry, intimate knowledge of cGMP requirements for Australia, EU and the US, including ISO Standards specifically (ISO 13485) and 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for combination products, nanoparticles, powder fills, biological medicines, and the principles and concepts of relevant quality processes and systems are mandatory.
  
You will have formal qualifications in a Scientific or related discipline.

Other Requirements

• Must be eligible to work in Australia

If you are looking for a unique opportunity to join a true global leader in a role that will enable you to make a key contribution to the company's growth this is the role for you.

On application you will be redirected to the Pfizer Careers website to register your details under the "My Profile" section. Once you have completed the registration process, please search and apply for this opportunity, 4706578. Applications close 4 July 2018.

Disclaimer:

Pfizer does not accept unsolicited agency resumes. Pfizer is not responsible for any fees related to unsolicited resumes.