04 ott - Italia
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FILIALE: FROSINONESPECIALIZZAZIONE: CORE SKILL - Life Science
Grafton LifeScience* is a dedicated team focused on enhancing the experiences, skills, and potential of candidates in Sales & Marketing, Clinical Research, Regulatory, and Operations within the Pharmaceutical and Medical sectors. We also specialize in roles related to customer support in the health-impacting distribution field (Pharmacies and Parapharmacies).
In partnership with an integrated CDMO with around 60 locations worldwide, specializing in integrated sterile liquid and lyophilized product development and commercial manufacturing, we offer an opportunity for
Production Quality Specialist
Summary
The main function of a Quality Specialist is to ensure compliance within the Manufacturing Department by managing documentation, CAPAs, deviations, and audits. This role supports continuous improvement initiatives and collaborates across departments to uphold quality standards in a fast-paced, regulated environment.
Job Responsibilities
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.
Do you have these skills and requirements?
Requirements: 1–2 years
Previous work experience (not necessarily in the same role) in sterile manufacturing/production departments
Knowledge of GMP regulations
English (written and spoken) B2
Preferred skills
Participation in regulatory audits
Participation in internal and external audits
Quality Assurance in a manufacturing/production environment
Qualifications
Bachelor's degree (3-year) in a scientific discipline
Contract Offer
Fixed-term agency contract 05/10/
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