Pharma Quality Specialist - Sterile Manufacturing

GI GROUP S.P.A.; Lazio; In loco; EUR 28.000 - 40.000; Part-time

Descrizione del lavoro

GI GROUP S.P.A. (Grafton LifeScience) seeks a Production Quality Specialist to ensure manufacturing compliance, manage CAPAs, deviations, and audits in a fast-paced, regulated setting. The role collaborates across departments to uphold quality standards.

The candidate will support the production department with documentary control, change controls, SOP reviews, and training activities, while addressing quality issues with cross-functional teams and leading audits.

Competenze

• Bachelor's degree required in a scientific discipline.
• 1–2 years experience in sterile manufacturing/production mentioned in job.
• Knowledge of GMP regulations.

Mansioni

• Provide documentary support to the production department.
• Manage CAPAs using the TrackWise system.
• Coordinate the opening and management of Change Control Forms (CCFs).
• Collaborate with the Quality System Department to review and update SOPs.
• Conduct and manage departmental training activities.
• Prepare and present compliance documents and procedures.
• Identify and resolve quality issues in collaboration with relevant teams.
• Manage internal, customer, and regulatory audits.

Conoscenze

GMP knowledge

English (B2)

Formazione

Bachelor's degree in scientific discipline

Strumenti

TrackWise

Descrizione del lavoro

GI GROUP S.P.A. (Grafton LifeScience) seeks a Production Quality Specialist to ensure manufacturing compliance, manage CAPAs, deviations, and audits in a fast-paced, regulated setting. The role collaborates across departments to uphold quality standards.

The candidate will support the production department with documentary control, change controls, SOP reviews, and training activities, while addressing quality issues with cross-functional teams and leading audits.