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 o 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!