Quality Assurance Operations Analyst II

As a Quality Assurance Operations Analyst II, you ensure that manufacturing and product release activities are carried out in accordance with licenses, applicable regulations, internal requirements, and customer expectations.

With your in-depth knowledge of quality systems and manufacturing and release processes, you act as a subject matter expert in your area of expertise. You support and influence partners to promote a strong quality culture and ensure operational compliance.

Responsibilities:

• Review and approve production records, master data, validation documents, and other required GMP documents based on complexity, criticality, and applicable requirements.
• Monitor quality deliverables associated with operational activities and product release according to established priorities and deadlines.
• Propose, verify, and authorize quality statuses in applicable systems, ensuring data consistency and decision traceability.
• Review and approve investigations, corrective and preventive actions (CAPA), and related tasks to ensure robustness and compliance.
• Assess the quality impact of deviations or situations that may affect compliance and contribute to defining appropriate actions.
• Provide quality assurance support to partners regarding GMP, quality systems, documentation, and operational issues.
• Maintain regular presence on the floor, including during tours and aseptic activities, to observe practices, support compliance, and manage unplanned events.
• Develop, execute, and document quality assurance activities, management follow-up, and quality follow-ups.
• Write, revise, or update sector GMP documents, including SOPs, LRP, release documents, AQL reports, PQR, and other applicable quality documents.
• Exercise critical judgment to prioritize deliverables, escalate issues based on criticality, represent the sector during inspections, audits, or quality interactions, and act as a subject matter expert or trainer as needed.

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., chemistry, biochemistry, microbiology).
• 3 years of relevant experience in pharmaceutical quality assurance.
• Intermediate computer skills (Office Suite).
• Intermediate English language skills (written).
• Knowledge of GMP.

Benefits:

• On-site cafeteria
• Free gym membership for employees
• Accessible by public transportation
• Free parking