ROLES & RESPONSIBILITIES

As the Engineering Compliance Specialist, you will act as departmental SME for site quality systems (CAPA, Change Control, Compendial Assessments, Documentation Management, Annual Product Quality Review).

CAPA & Investigations

• Supporting and managing CAPA process to drive an optimisation of CAPAs, investigations and other similar actions (inclusive of generation/analysis of KPIs).
• Provide technical support on investigations, CAPA actions and defining appropriate closure dates.
• Represent and advocate for Engineering Department in CAPA review forums and share outcomes to other engineering colleagues.
• Ensure the standard of Engineering Investigations and CAPAs are in line with regulatory requirements.
• Support central investigations team in the management of investigations as required.

Change Control & Documentation

• Manage documentation periodic reviews for all engineering documentation and provide a central point of contact for documentation standards and requirements.
• Act as departmental system/process SME for change control. This will be through support engineering colleagues in the development, progression, management and execution of change controls
• Develop and manage the library of templates to support ease of use and standardization of documents across Engineering.
• Provide timely review of documentation change requests ensuring new and existing procedures are process mapped and impact assessed appropriately.
• Attend CCC to present Change Controls on behalf of Engineering (as required).

Other Quality Systems

• Departmental primary contact for regulatory and internal audits and support the development/finalisation of observations responses.
• Responsible for the management of PQS/Regulatory change reviews for engineering systems.
• Ensures appropriate immediate actions are taken following quality/safety incidents to support compliant ongoing manufacture and/or product quality.
• Defines and implements CI strategies to improve effectiveness and efficiencies of processes.
• Act as departmental representative for Site Quality Review.
• Manage departmental APQR and compendium reviews
• Provide support to the Engineering department and projects (as required)
• Support the delivery of inspection readiness programs associated with engineering

QUALIFICATIONS

• Formal qualification in Chemistry, Science or Engineering preferrable.
• Demonstrated knowledge of cGMP and Regulatory requirements for Australia, US and EMEA
• Demonstrated experience in internal and external auditing processes
• Experience in deviation, CAPA and change control management within the pharmaceutical cGMP environment.
• Six Sigma Yellow/Green/Black Belt certification preferable

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

• Paid parental leave

• Access to Health & Wellness apps

• Career Growth Experiences program

• Recognition & rewards program

• Paid volunteer days

• Life Insurance Benefits

• Pfizer Learning Academy access to top content providers

• Access to flu vaccines & skin checks

• Options to purchase additional leave

• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.