Job Responsibilities
Support continuous improvement programs to establish an effective Quality Management System.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering for project / technology transfer.
Effectively execute tasks related to Drug Product processes.
Assess, review, and approve quality records such as deviations, change control, CAPAs, investigations, effectiveness checks, and extensions in line with current local 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 a 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 executive batch records and prepare batch release documentation, including recommendations on disposition status.
Support and manage interactions concerning changes, deviations, technical complaints, out-of-specification results, etc.
Delegate FvP responsibilities for Batch Disposition of Drug Product.
Qualifications and Experience
Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, or a related scientific discipline; advanced degree preferred.
5+ years of experience in pharmaceutical or biotech industry, specifically in Quality Assurance for Drug Product manufacturing.
Deep understanding of GMP regulations (EU, FDA, ICH) and experience with audits/inspections by health authorities and customers.
Experience with QMS tools, including CAPA, change control, deviation management, SOP authoring, KPI tracking, and risk assessments.
Proven ability to collaborate effectively with Manufacturing, QC, Engineering, and Project Management teams in a matrix environment.
Strong communication skills, both written and verbal, capable of representing QA in customer meetings, regulatory inspections, and internal governance structures.
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