Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description PURPOSES OF THE POSITION/RESPONSIBILITIES: Support the Team Leader QA Training & Documentation in ensuring the compliance of the company with current quality regulations (laws, GMP, AIFA, FDA, etc.) normative. The GMP Documentation Specialist will play a crucial role in ensuring that all documentation related to GMP compliance and quality assurance is accurately crafted, maintained, and managed. This role requires meticulous attention to detail, a strong understanding of regulatory guidelines, and effective interpersonal skills.
Support the Team Leader QA Training & Documentation in participation to internal and external audits.
SPECIFIC ASSIGNMENTS/PRIMARY ACTIVITIES: Document Control: Ensure GMP documentation in compliance with regulatory requirements and internal quality standards. Ensure SOP periodic review executed on time. Manage the Logbooks linked to operative departments (control, closing and opening). Analyze the improvement areas for the documentation process flow, logbooks and forms. Document Creation, Review and Managing: Collaborate with cross-functional teams to create and review GMP documents, ensuring accuracy, transparency, and compliance with regulatory standards. Coordinate internal function to align site GMP documentations according to Corporate or Global GMP documentation (e.g. GSOP, Policies, WI) Manage document revision processes, track changes, and maintain an audit trail of all SOP/Form/WI/JA versions. Quality Assurance: Collaborate with quality operations teams to facilitate investigations, root cause analysis, and corrective and preventive actions (CAPA) related to documentation issues. Assist in both internal and external audits by providing accurate and organized documentation for inspection. CAPA, deviation and quality records management according to required on time. Keep update the department SOP's. Support to develop an electronic way to reduce paper document in order to simplify the group and site activities. Management and monitoring of documentation process performance indicators (KPI). RELATIONS: Internal All site functions. External NA REQUIREMENTS AND QUALIFICATIONS: ESSENTIALS Education: Master's degree in Chemistry, CTF, Pharmacy or Biology OR at least 3 years of experience in a pharmaceutical company in a similar role.
Technical skills: Knowledge of Microsoft Office package. Professional experiences: Knowledge of GMP principles, regulations, guidelines with a strong understanding of Health authorities FDA and international regulatory requirements. At least 1 year experience in a similar role in the pharmaceutical. Languages: Italian and English.
Personality Traits: Orderly, encouraging, cheerful.
DESIDERABLES: Strong attention to detail and excellent interpersonal skills. Proficiency in document management software and Microsoft Office applications. Excellent written and verbal communication skills. Ability to work in a team and collaborate across different departments. Energy, dedication, enthusiasm and passion that are reflected in the ability to (self)motivate and empower others. Join us!
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