In this role, you will be responsible for supporting the quality management system, ensuring compliance with GMP standards, and collaborating with cross-functional teams to facilitate smooth manufacturing and project transfers. You will review and approve quality documentation, participate in audits, and serve as a key point of contact for QA-related questions. Additionally, you will oversee batch releases and manage customer interactions related to quality topics.

Start Date: 01/06/2025

Duration: 7 Months

Key Responsibilities

  • Support continuous improvement initiatives to strengthen the Quality Management System
  • Represent QA in cross-functional teams, liaising with manufacturing, QC, support functions, and engineering for process transfers
  • Review, assess, and approve quality records such as deviations, change controls, CAPAs, investigations, and effectiveness checks
  • Author, review, and approve GMP-related documents and SOPs to ensure compliance
  • Present Drug Product QA topics during customer audits and regulatory inspections
  • Participate in internal audits as needed and organize monthly Quality Council meetings
  • Track and report key quality indicators and maintain the KPI dashboards
  • Conduct gap assessments for audits and inspections at other facilities
  • Support daily HOSHIN Tier 1 and Tier 2 updates and act as back-up for QA leadership in HOSHIN processes
  • Act as primary contact for QA questions related to manufacturing operations and project-specific risk assessments
  • Review and approve process documentation, batch records, and transfer documents
  • Support batch release activities, including reviewing executive batch records and making disposition recommendations
  • Manage customer interactions concerning deviations, complaints, and deviations from quality standards
  • Act as delegate for batch disposition and conditional release decisions

Candidate Profile

  • Proven experience in Quality Assurance within a GMP-regulated environment
  • Strong understanding of pharmaceutical manufacturing processes and quality systems
  • Excellent documentation review and approval skills
  • Experience with regulatory audits and customer interactions
  • Ability to work collaboratively across multiple teams and functions
  • Detail-oriented with strong organizational skills and problem-solving abilities
  • Fluent in English, with good communication skills
  • Prior experience in batch release and risk assessment is a plus

 

Job ID 41180594