02 ott - Frosinone
GiGroup H-7241
Qa - Production Quality Specialist Luogo di lavoro: FrosinoneGrafton 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 SpecialistSummary: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 yearsPrevious work experience (not necessarily in the same role) in sterile manufacturing/production departmentsKnowledge of GMP regulationsEnglish (written and spoken) B2Preferred skills:Participation in regulatory auditsParticipation in internal and external auditsQuality Assurance in a manufacturing/production environmentQualifications:Bachelor’s degree (3-year) in a scientific disciplineContract Offer: Fixed-term agency contract 0
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