Qa Validation Supervisor Monza

Qa Validation Supervisor
Monza
Lombardia, Monza

Work Schedule

Standard (Mon-Fri)

**Environmental Conditions

Office

**Responsibilities**:

Lead a team at Thermo Fisher Scientific Inc. as a QA Validation Supervisor.

Ensure flawless quality and compliance.

- Review the Validation Master Plans for Process and Cleaning, following current regulations (GMP, FDA, etc. )

and company quality standards.

- Validation Documentation: Guarantee the accuracy and quality of validation and revalidation documentation for equipment, production, and cleaning processes through meticulous review and coordination.

- Validation Reports: Coordinate the correctness and quality of Validation Reports, ensuring compliance with the Validation Master Plan and SOPs.

- Audit Support: Assist in preparing for and participating in external audits by providing necessary information and documentation.

- Change Control: Coordinate change control activities related to the introduction of new products, ensuring alignment with company procedures.

- SOP Updates: Ensure continuous updates of SOPs and related documentation, adhering to GMP requirements.

- Team Management: Lead and develop your team by setting clear objectives, recognizing achievements, and addressing training needs.

**Job Requirements**:

Essential Qualifications:

- Education: Degree in Pharmacy, Biological Sciences, Chemistry, or Chemical Engineering.

Equivalent experience in Pharmacy, Biological Sciences, Chemistry, or Chemical Engineering is also acceptable.

- Technical Skills: Familiarity with pharmaceutical processes, Microsoft Word and Excel, basic analytical methods, statistical analysis software, and pharmaceutical legislation.

- Experience: Proven experience in equipment, process, and cleaning validation, aseptic production, and quality assurance.

- Language Skills: Excellent written and spoken English.

- Personal Traits: Strong interpersonal skills, attention to detail, organizational abilities, and a sense of dedication to quality.

**Desirable Qualifications**:

- In-depth knowledge of pharmaceutical legislation.

- Advanced analytical techniques (chemical and microbiological).

- Experience in personnel management.