Automated Systems Quality Specialist

2 weeks ago

Mulgrave, Victoria, Australia Pfizer Full time
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 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.

How You Will Achieve It

  • Coordinate, and where applicable perform assessments to determine:
  • The state of compliance of automated systems to applicable regulations (e.g. 21 CFR Part 11, PIC/S Annex 11)
  • The Validation status of automated systems
  • Ensure that automated systems regulations are correctly interpreted and carried through into current policies and compliance related procedures and actioned appropriately.
  • Facilitate, direct and monitor prospective and remediation compliance initiatives for automated systems (Laboratory, Engineering/Plant, Pfizer Core Systems, Information Technology systems) within Pfizer Melbourne.
  • Coordinate, and where applicable, participate in the creation, review and approval of procedures, plans and guidelines to ensure that existing automated systems remain in a compliant state and new automated systems are implemented in accordance with the latest regulatory standards.
  • Provide guidance and assistance for the implementation of new systems in relation to validation and compliance issues by educating and mentoring key staff on the need for, and mechanisms of, ensuring compliance of GXP systems with relevant regulations.
  • Act as a stand in for the Automated Systems Quality Manager, or other appropriate quality positions as assigned by the Manager, in the absence of these staff members or as required.
  • Participate in external and/or internal audits for operational areas as defined by incumbent experience and qualifications (e.g., manufacturing, laboratory) as required.
  • Keep abreast of new technologies and changes in regulatory and Pfizer policy standards.

Qualifications:

Must-Have

  • Degree, Masters, Graduate Diploma or equivalent in Computing or Engineering from a recognized institution
  • 2+ years collective experience in the Pharmaceutical industry (Validation, Quality Assurance, Information Technology)
  • Good understanding of GMP, GDP, ALCOA principles, 21 CFR part 11 and PIC/s (Annex 11)
  • Strong project management skills
  • Strong communication (written and verbal) skills
  • Excellent facilitation skills and ability to facilitate strategy meetings
  • Expertise with wordprocessing, spreadsheet and presentation software
Nice-to-Have

  • Degree, Masters, Graduate Diploma, Diploma or equivalent in Science from a recognized institution would be an advantage
  • 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 laboratory systems, automated manufacturing systems (SCADA, PLC, HMI), Network Qualification
  • Experience in Validation principles and validation documentation

Work Location Assignment:
On Premise

Quality Assurance and Control

LI-PFE

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