10 часов назад
Regional Environmental Monitoring Expert
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regional Environmental Monitoring Expert (GMP/Pharmaceutical Manufacturing): Evaluating and trending viable and non-viable particle data for qualified cleanroom areas with an accent on report generation, deviation assessment, and regulatory compliance. Focus on interpreting microbiological data, investigating quality events, supporting audits and inspections, and driving standardization and digitalization of environmental monitoring processes.
Location: Bogotá, Colombia; hybrid work with up to 50% remote work
Company
is a global life sciences company developing healthcare solutions across vaccines, rare diseases, oncology, immunology, infectious diseases, diabetes, and cardiovascular care.
What you will do
- Evaluate and trend viable and non-viable particle data from qualified cleanroom areas.
- Interpret environmental monitoring results, identify adverse patterns, and prepare timely and annual reports.
- Assess trends, deviations, CAPAs, and quality events, documenting potential impacts and supporting investigations.
- Collaborate with site-specific subject matter experts and incorporate technical input into reports and conclusions.
- Support audits, regulatory inspections, and corporate assessments with accurate, complete, and compliant documentation.
- Drive standardization, simplification, digitalization, and continuous improvement of environmental monitoring processes.
Requirements
- 5–7 years of experience in GMP environments, including ideally 3+ years in environmental monitoring or a related reporting function.
- Experience analyzing and trending microbiological data, interpreting results, and identifying adverse patterns.
- Background in microbiology, pharmaceutical chemistry, or a related field.
- Strong attention to detail, stakeholder management, communication, critical thinking, root cause analysis, organization, and teamwork skills.
- Advanced English proficiency is mandatory.
- Ability to work in accordance with cGMP, GxP, HSE, quality management, and regulatory requirements.
Culture & Benefits
- Flexible hybrid working policies, including up to 50% remote work.
- Private medical care, life and health insurance, and gender-neutral paid parental leave.
- Opportunities for career growth through promotions and lateral moves, including international opportunities.
- Work in a diverse, cross-cultural environment with opportunities to contribute to business impact.
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