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5 дней назад

Sterility Assurance Lead (Pharma)

86 400 - 129 600CAD
Формат работы
onsite
Тип работы
fulltime
Грейд
lead
Английский
b2
Страна
Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sterility Assurance Lead (Pharma): Ensuring sterility assurance, environmental monitoring, and microbial control compliance for Baxter's regulated healthcare manufacturing operations with an accent on GMP, aseptic processing, and regulatory standards. Focus on leading environmental performance qualifications, investigating sterility exceptions, maintaining SOPs, and coordinating cross-functional risk assessments.

Location: Mississauga, Ontario, Canada. Day shift, Monday to Friday, 8:00–17:30.

Estimated annual salary: CAD 86,400–129,600, including base salary and estimated target payout under the Management Incentive Compensation Plan.

Company

hirify.global develops and delivers healthcare products and solutions focused on saving and sustaining lives.

What you will do

  • Ensure compliance of the CIVA Sterility Assurance program with regulatory and corporate requirements.
  • Direct the Environmental Monitoring program and maintain alignment with applicable standards.
  • Investigate sterility assurance exceptions and represent the function in professional forums and communities of practice.
  • Lead cross-functional Environmental Performance Qualifications and Real Time Risk Assessments.
  • Advance the Environmental Monitoring program and maintain the Microbial Control Scheme and Plan.
  • Keep local SOPs current and aligned with corporate and regulatory standards.

Requirements

  • Bachelor of Science degree in Pharmacy, Microbiology, Chemistry, or Biology.
  • 3–5 years of relevant experience in a GMP-regulated industry.
  • Strong understanding of aseptic technique and GMP requirements.
  • Strong problem-solving, critical-thinking, analytical, prioritization, and autonomous-working skills.
  • Technical expertise in cleanrooms and aseptic processing is preferred.
  • Experience leading teams and providing mentorship is preferred.

Culture & Benefits

  • Quality-focused environment where patient safety takes priority over quantity.
  • Opportunities to collaborate across plant and office settings while also working independently.
  • Culture built around reliability, ethics, accountability, trust, and continuous improvement.
  • Equitable pay practices and an incentive plan tied to company and individual performance.
  • Reasonable accommodations are available throughout the application and interview process.

Hiring process

  • AI tools may assist with candidate screening and qualification evaluation.
  • Final hiring decisions are made by the hiring manager and recruitment team.
  • Interviewed candidates will be notified of the outcome within 45 days of the interview.

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