14 часов назад
Lead Specialist, Compliance (Audit Management), QA
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Lead Specialist, Compliance (Audit Management), QA (GxP and GMP): Supporting audit activities and quality operations at a multi-product biopharmaceutical contract manufacturing facility with an accent on regulatory inspections, customer audits, and quality management systems. Focus on preparing audit walkdowns, leading inspection responses and complex deviation investigations, and developing expertise as an internal GxP auditor and subject matter expert.
Location: Fully site-based at the Tuas facility, Singapore
Company
is a global life sciences company manufacturing medicines across more than 30 sites on five continents.
What you will do
- Support audit activities in accordance with approved SOPs and policies at a multi-product, cGxP contract manufacturing facility.
- Develop capability as an internal GxP auditor and support regulatory inspections and customer audits.
- Lead audit walkdown preparation and provide feedback to relevant stakeholders.
- Lead audit and inspection responses.
- Lead complex deviation investigations and own assigned quality process documents.
- Develop as a qualified trainer and subject matter expert in an area of expertise.
Requirements
- Bachelor’s degree with relevant experience in Quality Assurance within the biopharmaceutical sector.
- Proven QA operations experience in a GMP-regulated biopharmaceutical environment.
- Practical experience collaborating with cross-functional manufacturing teams.
- Solid understanding of quality management systems and GMP compliance requirements.
- Familiarity with FDA, EMA, and ICH regulatory guidelines.
- Strong analytical, problem-solving, communication, organizational, and teamwork skills, with attention to safety, quality, and timelines.
Culture & Benefits
- Inclusive and ethical workplace focused on diversity, integrity, collaboration, accountability, excellence, and passion.
- Competitive compensation programs and comprehensive medical insurance, with partially subsidized family coverage available.
- Professional growth through cross-functional projects and global exposure.
- Company transport from designated MRT locations to and from the Tuas site.
- Access to ’s full employee benefits program.
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