Investigations Specialist

Job Description

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

In this role, you will be responsible for addressing site deviations by conducting thorough investigations and root cause analyses to identify effective Corrective and Preventative Actions (CAPAs). Your efforts will help reduce the number of repeat deviations at the site. Additionally, you will be responsible for driving improvements through independent proactive CAPAs and Continuous Improvement (CI) ideas from production. Your role includes implementing strategies to enhance performance and reduce waste, driven by proactive CAPAs and CI initiatives, and reporting performance against established standards in line with company objectives.

You will be accountable for meeting department, site, and corporate goals and will be expected to report and communicate progress on deviations, status, and closure plans to key stakeholders across the business.

How You Will Achieve It

• Lead complex investigations and create effective project plans to ensure timely closure, engaging site Subject Matter Experts (SMEs), managing meetings, and reporting investigation updates to key personnel across the site.
• Serve as an Operations technical SME in cross-functional Method 1 (M1) investigations.
• Utilize Six Sigma investigation tools, including MiniTab, Fishbone, and 5 Whys methodologies, for true root cause identification and effective CAPA implementation.
• Drive timely closure and quality improvements to reduce repeat deviations, increase performance, and reduce waste and costs.
• Proactively engage with Operations staff to identify CI initiatives, focusing on safety, quality, compliance, and Materials Usage Variance (MUV)/cost reduction.
• Provide continued education and mentoring to Operations staff on the importance of proactive data analysis, investigation methods, CI identification, and root cause and CAPA determination, fostering a positive working environment and resilience.
• Initiate and deliver Change Controls (CC) related to CAPAs and CI initiatives, ensuring timely closures.
• Present Operations investigation findings during Regulatory inspections and Contract Customer Audits.
• Monitor and report deviation performance metrics as directed.
• Perform any other duties as assigned by the Production Compliance Lead.

Qualifications

Must-Have

• Bachelor’s degree in science, Pharmacy, Engineering, or a related discipline, or equivalent experience in the pharmaceutical or allied industry.
• 3-5 years of experience in pharmaceutical manufacturing/Quality.
• 1-3 years of experience in facilitating investigations using Six Sigma tools, Fishbone, and 5 Whys methodologies for root cause analysis and effective CAPA identification.
• Knowledge and application of Good Manufacturing Practices (cGMP).
• Experience with compliance issues resulting from cGMP deviations or product defects.
• Exceptional communication, negotiation, interpersonal, and leadership skills (both 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 the management of deviation investigations, change controls, and quality records.
• Proficiency with computer packages, including the Microsoft Office suite.
• Permanent rights to work within Australia.
• Deviation investigation experience within the pharmaceutical cGMP environment.

Nice-to-Have

• Experience in sterile manufacturing, Process Validation, Engineering, or Quality.
• Method 1 (M1) & Pfizer Human Performance (PHP) certification.
• Lean Six Sigma Yellow/Green/Black Belt certification.
• Experience with MiniTab and TrackWise Quality Management System.

  
Work Location Assignment: On Premise

 
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

*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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Manufacturing