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Senior Specialist, QA External Manufacturing

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Alfasigma

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Location:
Italy , Pomezia

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Senior QA Specialist – External Manufacturing is responsible for ensuring quality and compliance of pharmaceutical and Consumer Healthcare (CHC) products manufactured at Contract Manufacturing Organizations (CMOs). The role combines hands-on Quality Assurance activities with advanced oversight of investigations, risk assessments, and change controls. This position acts as a key quality contact for assigned external sites, contributing to supplier governance, continuous improvement initiatives, and product lifecycle management, while ensuring compliance with GMP, GDP, ICH guidelines, and internal company standards.

Job Responsibility:

  • Serve as the primary QA contact for assigned CMOs, monitoring performance through quality metrics, documentation review, and regular governance meetings
  • Support batch review and release activities, ensuring thorough evaluation of manufacturing and packaging records, analytical results, deviations, and associated changes
  • Review and manage deviations, investigations (including OOS/OOT), and CAPAs, ensuring scientific soundness, robustness, and timely closure
  • Assess change controls from CMOs, collaborating with cross-functional teams (Regulatory, MS&T, Supply Chain, Procurement) to ensure compliant implementation
  • Participate in internal audits, CMO audits, and regulatory inspection readiness activities, following up on corrective actions
  • Maintain and update Quality Agreements to reflect current operations and compliance requirements
  • Drive continuous improvement initiatives related to quality systems and external manufacturing performance
  • Support technology transfers, scale-ups, and new product introductions from a QA perspective
  • Partner with Technical Operations and MS&T to enhance processes and product quality

Requirements:

  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related field
  • 3–5+ years of experience in a GMP Quality Assurance role within the pharmaceutical or CHC industry
  • Experience in external manufacturing or supplier quality (strongly preferred)
  • Solid knowledge of EU/FDA GMP regulations, ICH guidelines, and quality management systems
  • Strong ability to review complex documentation with accuracy and attention to detail
  • Problem-solving skills with experience in root cause analysis
  • Excellent communication skills to effectively interface with internal stakeholders and external partners
  • Ability to manage multiple priorities and work independently with moderate supervision
  • Familiarity with digital quality tools and AI applications
  • Proficiency in English
  • additional languages are a plus

Nice to have:

  • Experience in external manufacturing or supplier quality
  • Additional languages
What we offer:
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development

Additional Information:

Job Posted:
March 22, 2026

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