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Pfizer

Investigations Specialist (6 Months Fixed term )

Posted 2 Days Ago
Be an Early Applicant
Victoria
Senior level
Victoria
Senior level
As an Investigations Specialist, you'll manage team activities, develop and validate manufacturing processes, create and review documentation, troubleshoot investigations, lead compliance initiatives, and provide expert input during regulatory inspections.
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Use Your Power for Purpose
Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.
What You Will Achieve
In this role, you will:

  • Manage time effectively to meet targets and develop plans for team-based work activities, contributing to the completion of complex projects.
  • Develop and validate manufacturing processes for drug products, ensuring compliance and data integrity.
  • Create and review cGMP documentation, including batch records, cleaning assessments, and SOPs.
  • Support manufacturing by troubleshooting investigations and implementing Corrective Action/Preventative Action to prevent issues.
  • Provide expertise in operations for new lines and processes directly associated with.
  • Lead environmental tasks, initiatives, training, and services in compliance with Pfizer Global Environment, Health & Safety Standards, and regulatory requirements.
  • Offer subject matter expert input during regulatory inspections.
  • Use judgment to modify methods and techniques as needed.


Here Is What You Need (Minimum Requirements)

  • High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
  • Strong understanding of cGMP and regulatory requirements
  • Proficiency in troubleshooting and problem-solving within a manufacturing environment
  • Excellent communication and organizational skills
  • Ability to work independently and as part of a team
  • Experience with process validation and documentation
  • Familiarity with environmental, health, and safety standards


Bonus Points If You Have (Preferred Requirements)

  • Experience in a pharmaceutical manufacturing environment
  • Knowledge of Lean Manufacturing principles
  • Proficiency in data analysis and statistical tools
  • Strong project management skills
  • Ability to mentor and train junior colleagues
  • Experience with regulatory inspections and audits
  • Strong attention to detail and commitment to quality
  • Ability to adapt to changing priorities and work in a fast-paced environment


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.
Manufacturing
#LI-PFE

Top Skills

Cgmp
Data Analysis
Lean Manufacturing Principles
Statistical Tools

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