Gmp Documentation Specialist

2 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

**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 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.
- 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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