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
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