Senior GDP QA Specialist | Remote Quality Assurance Leader

Chiesi; Parma; Ibrido; EUR 41.000 - 51.000; Tempo pieno

Descrizione del lavoro

Chiesi is seeking a Senior GDP QA Specialist to strengthen the GDP Quality Management System in a dynamic pharmaceutical environment. You will own core GDP QA activities, autonomously manage deviations, CAPA, change control, audits, and temperature excursions, and support regulatory inspections while aligning with GDP requirements.

The candidate should have a scientific/technical qualification with 8+ years of experience, strong analytical and problem-solving skills, and the ability to work

Competenze

• Qualification in a scientific or technical discipline and/or 8+ years of relevant industry experience.
• Knowledge of quality standards and regulatory guidelines for pharma/biotech products.
• Demonstrated skills in quality activities as described above.
• Experience in project management, analytical and problem solving.
• Good prioritisation and ability to adapt to changing priorities.
• Ability to work autonomously and make timely, risk-based decisions.
• Excellent interpersonal and collaboration skills.

Mansioni

• Manage deviations, CAPA, Change Control, audits (internal, supplier, customer), distribution complaints, supplier qualification, customer/supplier quality agreements, shipping and transportation validation, and record retention.
• Participate in investigations and support effectiveness checks of CAPA.
• Ensure quality risk management documentation is complete and up to date.
• Manage or support recall operations promptly.
• Support evaluation/management of returned, rejected, recalled, or falsified products.
• Review temperature excursions and assess release decisions.
• Ensure customer complaints are handled efficiently and documented.
• Oversee subcontracted GDP-impacting activities when delegated.
• Support regulatory inspections and 3PL/customer audits.
• Define quality metrics and participate in internal/external meetings.
• Represent the GDP QA department as needed and deputize for GDP QA Manager.

Conoscenze

Quality standards

Regulatory guidelines

Quality activities

Project management

Analytical skills

Problem solving

Prioritization

Autonomous work

Interpersonal skills

Formazione

Scientific or technical discipline

Descrizione del lavoro

Chiesi is seeking a Senior GDP QA Specialist to strengthen the GDP Quality Management System in a dynamic pharmaceutical environment. You will own core GDP QA activities, autonomously manage deviations, CAPA, change control, audits, and temperature excursions, and support regulatory inspections while aligning with GDP requirements.

The candidate should have a scientific/technical qualification with 8+ years of experience, strong analytical and problem-solving skills, and the ability to work