Production Compliance Specialist

Why Patients Need You

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, production, compliance, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

What You Will Achieve

As the Production Compliance Specialist, you will be instrumental in supporting the production teams by managing change requests and updating documentation, including but not limited to master supporting documents. You will oversee associated change controls and assist with scheduled periodic reviews to ensure all documentation aligns with company policies, practices, and standards. Your role encompasses implementing strategies to improve performance and reduce waste through proactive CAPAs and Continuous Improvement (CI) initiatives, as well as reporting performance against established standards in line with company objectives. You will be accountable for meeting department, site, and corporate goals and will report and communicate the status of manufacturing compliance activities and closure plans to key stakeholders.

How You Will Achieve It
- Supporting the production teams by managing change requests and updating documentation.
- Manage associated change controls and assist with the scheduled periodic review of production documentation.
- Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
- Update documentation to align with company policies, practices, and standards.
- Implement strategies to improve performance and reduce waste through proactive CAPAs and CI initiatives.
- Preparing monthly and or weekly departmental metrics related to change control and document control processes.
- Report performance against established standards in line with company objectives.
- Participate in risk assessment activities.
- Communicate the strategic plan objectives of the department in daily activities.
- Foster an environment of open communication and recognition of contribution.
- Collaborate with business process owners to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
- Perform all operations within the Functional Unit according to relevant procedures and standards.
- Facilitate or complete production compliance activities outside standard working hours as needed.
- Conduct complex data gathering and analysis using Excel and MiniTab.

Qualifications

Must-Have
- Bachelor’s degree in science, Engineering, or a related discipline, or equivalent experience in the pharmaceutical or allied industry.
- 3-5 years of experience within the pharmaceutical or allied industry.
- Exceptional communication, negotiation, interpersonal, and leadership skills (verbal and written).
- Results-focused with demonstrated Project Management skills, the ability to manage multiple projects, and meet business targets and delivery timelines.
- Attention to detail, technical knowledge, innovative thinking, and problem-solving abilities, including implementation of resolutions.
- Ability to work under pressure and meet agreed timelines with high attention to detail.
- Understanding of quality systems, including CAPA/CI management, change controls, and quality records.
- Proficiency with computer packages, including the Microsoft Office suite.
- Permanent rights to work within Australia.

Preferred Qualifications
- Experience in sterile manufacturing, Process Validation, Engineering, or Quality.
- Method 1 (M1) and Pfizer Human Performance (PHP) certification.
- Demonstrated ability and accountability to meet business targets and objectives.
- Strong awareness of GxP requirements and a proponent of “Best-Practice” Quality Standards.
- Demonstrated initiative and ownership in resolving issues or challenges.
- Participation in the generation and implementation of continuous improvement (CI) ideas.
- Ability to occasionally work outside standard hours to accommodate all production shifts and business needs.

Work Location Assignment: On Premise

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

Support Services

LI-PFE