Automated Systems Quality Specialist - Mulgrave, Australia - Pfizer

Pfizer

Verified Company

Mulgrave, Australia

1 week ago

Posted by:

Olivia Brown

beBee Recruiter

Description

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

In your role, you will be joining a team that is accountable for assuring the compliant validation of information technology systems.

Your work will involve creating/reviewing or approving formal validation documentation (including standard operating procedures) as per governmental regulations and coordinating activities with clients, programmers/developers and operating personnel, in-country or global, as appropriate.

As a Quality Specialist, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time.

Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

How You Will Achieve It- Contribute to the completion of moderately complex automation projects.- Manage own time to meet agreed targets.- Provide guidance and Quality oversight of the validation of automated Systems (Engineering, Manufacturing and Laboratory Equipment and Information Technology) ensuring compliance to applicable regulations.- Review and approve System Development Life Cycle (SDLC) documentation, investigations and change controls related automated systems.- Support site Data Integrity (DI) program, Change Controls, performing automated systems related investigations, as directed.- Review and approve the implementation/compliance documentation for GxP and non-GxP systems against good IT practices and regulatory codes for automated systems.- Implement available tools to ensure reduction of human performance related deviation.

Qualifications:

Must-Have- Bachelor's degree in a relevant field and 3+ years of experience ideally within the pharmaceutical industry- Good understanding of GMP, GDP, ALCOA principles, 21 CFR part 11 and PIC/s.- Strong project management skills.- Strong communication (written and verbal) skills.- Excellent facilitation skills and ability to facilitate strategy meetings.- Expertise with word-processing, spreadsheet and presentation software.

Nice-to-Have- Master's degree and relevant pharmaceutical experience.- Experience with system development and system administration requirements inclusive of Database Management Systems (DBMS), Application implementation, Network Infrastructure (network devices, servers, operating systems), IT security and Web Technologies.- Experience with automated manufacturing systems (SCAD, PLC, HMI), Network Qualification.- Experience with the implementation of Data Historians- Experience in Validation principles and validation documentation.

At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including: