Qualified Person – Malta based

About the role

PharOS is seeking an experienced Qualified Person (QP) to join its Quality Operations department in Malta. The QP will be responsible for ensuring that all pharmaceutical products are released in compliance with regulatory requirements and company standards.

Key responsibilities

• Prepare and periodically review standard operating procedures (SOPs).
• Act as a nominated QP on the company licence for product release to market or study sponsors.
• Maintain the quality system in line with relevant regulatory guidance.
• Investigate, document, and resolve non‑conformances and cGMP deviations.
• Approve and close customer complaint investigations, and manage critical complaints or recalls.
• Make final decisions on batch disposition, release, and certification for human consumption and IMP purposes.
• Ensure imported batches meet GMP Directive requirements.
• Lead product recall actions and notify authorities as required.
• Generate, review, and approve Product Quality Reviews.
• Participate in quality work‑groups and oversee equipment validation.

Required profile

• Qualified Person status recognized by the relevant EU Member State.
• Extensive experience in GMP/cGMP environments within pharmaceutical manufacturing.
• Strong knowledge of regulatory requirements for batch release, product recalls, and quality system management.
• Proven ability to lead investigations and manage product quality reviews.

Required skills

• GMP / cGMP compliance
• Batch release and certification
• Product recall management
• Quality system administration
• SOP development and maintenance
• Non‑conformance investigation