QA Specialist II (Validations)
Core
Ensure compliance with GMP standards and regulations across pharmaceutical operations, covering equipment, systems, processes, and documentation to guarantee product quality and safety.
Role type
QA Specialist (Validations)
Builds
Pharmaceutical products and compliant manufacturing processes
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
GMP compliance, Equipment Qualification (IQ/OQ/PQ), Process Validation, Data Integrity (ALCOA+), CAPA management, Deviation handling, OOS investigation, Supplier auditing, Documentation control, Sterile environment knowledge
Preferred skills
Blue Mountain software, Project startup experience, English language
Technologies
Blue Mountain
Responsibilities
Develop Standard Operating Procedures (SOPs) following GMP regulations; Implement and verify GMP application; Approve or reject manufacturing batches based on analysis and stability reports; Collaborate on technical documentation for products and materials; Qualify and validate equipment, systems, cleaning, processes, analytical methods, and stability studies; Prepare annual Product Quality Reviews (PQR); Approve R&D and Regulatory proposals related to product quality; Participate in client audits, conduct internal quality audits, and evaluate/homologate suppliers; Manage document control, data archiving, labeling control, and finished product shipment verification; Manage CAPAs, deviations, OOS results, customer complaints, and change controls.
Seniority
Mid-level (2-5 years experience)
