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Responsibilities
Support continuous improvement programs to establish an effective Quality Management System.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with Manufacturing, QC, Support Functions, and Project/Technology Transfer teams to effectively execute tasks related to Drug Product processes.
Assess, review, and approve quality records such as deviations, change controls, CAPAs, investigations, effectiveness checks, and extensions in line with current SOPs.
Author, review, and approve GMP-relevant documents and SOPs.
Present Drug Product QA topics during customer audits and regulatory inspections.
Participate in internal audits as required.
Organize and manage monthly Quality Council & Risk Register meetings.
Act as point of contact for Drug Product QA questions and issues related to manufacturing operations.
Support and approve project/product-specific risk assessments.
Review and approve product documentation such as process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists.
Review and approve batch records and prepare batch releases, including recommendations on disposition status.
Support and manage interactions related to changes, deviations, technical complaints, OOS results, etc.
Delegate FvP responsibilities for Batch Disposition and conditional release according to CHVI-4553 and CHVI-265873.
Qualifications and Experience
Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or related field; advanced degree preferred.
5+ years experience in pharmaceutical or biotech industry, specifically in QA for Drug Product manufacturing.
Deep understanding of GMP regulations (EU, FDA, ICH) and experience with audits/inspections.
Experience with QMS tools like CAPA, change control, deviation management, SOP writing, KPI tracking, and risk assessments.
Ability to work effectively with Manufacturing, QC, Engineering, and Project teams in a matrix environment.
Strong communication skills for representing QA in meetings, inspections, and governance structures.
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