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SOQ Senior Associate (Pharmaceuticals)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
SOQ Senior Associate (Pharmaceuticals): Implementing and maintaining the Quality Management System (QMS) at Country Offices to ensure compliance with regulatory expectations with an accent on deviation investigations and CAPA implementation. Focus on evaluating clinical and commercial drug batches, managing GxP supplier quality, and leading root cause analysis for quality deviations.
Location: Hybrid (Makati City, Philippines)
Company
is a global pharmaceutical corporation dedicated to delivering safe and effective medicines and vaccines to patients worldwide.
What you will do
- Maintain and implement the Quality Management System (QMS) to meet and Regulatory Authority expectations.
- Evaluate clinical and commercial drug batches to ensure documentation matches specifications and sampling procedures.
- Lead deviation investigations, conduct root cause analysis, and implement Corrective and Preventative Actions (CAPA).
- Manage GxP supplier qualification and quality oversight.
- Coordinate Health Authority inspections and internal audits of GMP/GDP activities.
- Perform local product release processes and oversee repackaging or relabeling activities.
Requirements
- Education: Bachelor of Science in Pharmacy (Licensed) is required.
- Location: Must be based in Makati City, Philippines for hybrid work.
- Minimum of 3 years of experience in the pharmaceutical industry, preferably in a quality role.
- Deep knowledge of current Good Manufacturing Practices (GMP) and applicable GxP regulations.
- Strong analytical skills and experience with Quality administered systems.
- Proficiency in Microsoft Excel and Word.
Nice to have
- 3-8 years of pharmaceutical experience with solid GMP/GDP Quality background.
- Advanced degree in Life Sciences or Regulatory Affairs.
- Training and proficiency in root cause analysis methodology.
- Project management and administrative technical capabilities.
Culture & Benefits
- Flexible, innovative, and customer-oriented quality culture.
- Opportunity to directly impact patient safety and product efficacy.
- Collaborative environment working with Global Regulatory Sciences and Global Supply Chain.
- Commitment to continuous improvement and professional development.
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