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Investigations Specialist

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Pfizer

2mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Melbourne
  • Quick Apply

AI generated summary

  • You need a Bachelor's in a relevant field, 3-5 years in pharma quality, root cause analysis experience, cGMP knowledge, strong communication skills, and the ability to manage multiple projects.
  • You will conduct investigations, analyze root causes, implement CAPAs, drive continuous improvement, mentor staff, report on metrics, and manage change controls to enhance performance and reduce waste.

Requirements

  • 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.

Responsibilities

  • 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.
  • 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.

FAQs

What is the main responsibility of an Investigations Specialist?

The main responsibility of an Investigations Specialist is to address site deviations by conducting thorough investigations and root cause analyses to identify effective Corrective and Preventative Actions (CAPAs) and to drive improvements through proactive CI initiatives.

What qualifications are required for the Investigations Specialist position?

A Bachelor’s degree in science, Pharmacy, Engineering, or a related discipline is required, along with 3-5 years of experience in pharmaceutical manufacturing/Quality and 1-3 years of experience in facilitating investigations using Six Sigma tools.

Are there specific methodologies that I need to be familiar with for this role?

Yes, experience with Six Sigma investigation tools, including Fishbone and 5 Whys methodologies, is essential for true root cause identification and effective CAPA implementation.

Is experience in a cGMP environment necessary?

Yes, deviation investigation experience within the pharmaceutical cGMP environment is a must-have qualification for this role.

What type of skills are emphasized for the Investigations Specialist role?

Exceptional communication, negotiation, interpersonal, and leadership skills are emphasized, as well as strong project management abilities, attention to detail, technical knowledge, and problem-solving capabilities.

Do I need certification for Lean Six Sigma?

While it's not mandatory, having Lean Six Sigma Yellow/Green/Black Belt certification is listed as a nice-to-have qualification for this position.

What benefits does Pfizer offer for this role?

Pfizer offers a range of benefits, including paid parental leave, access to health and wellness apps, career growth experiences, recognition and rewards programs, life insurance benefits, and options to purchase additional leave.

Where is this position located?

The Investigations Specialist role is assigned to be on-premise.

What kind of projects will I be managing in this role?

You will be responsible for managing complex investigations and creating effective project plans to ensure timely closure of deviations, as well as driving Continuous Improvement (CI) initiatives.

How does Pfizer ensure diversity and inclusion within the workforce?

Pfizer emphasizes diversity, equity, and inclusion through programs such as Colleagues Resource Groups (CRGs) and workstreams focused on Culture and Tradition, Reconciliation, Gender Equity, Disability, and support for LGBT+ colleagues and allies.

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Pfizer

Pharmaceutical Manufacturing

Science & Healthcare
Industry
10,001+
Employees
1849
Founded Year

Mission & Purpose

Pfizer is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative healthcare solutions. They are committed to improving the health and well-being of people around the world. Pfizer's mission is to be a leading force in the fight against diseases and to provide access to safe, effective, and affordable medicines. Their purpose is to make a positive impact on society by advancing medical science, developing breakthrough therapies, and collaborating with healthcare professionals and partners to address unmet medical needs. With a focus on research, development, and the production of pharmaceutical products, Pfizer plays a vital role in shaping the future of healthcare and improving patient outcomes.