Quality Specialist

5 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, boosting productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global network of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

As Qops/QS specialist you will become integral part of the Business unit responsible for the production of mRNA-based drugs and will put into practice your knowledge and expertise in the field of quality applied to pharmaceutical production processes to ensure that production takes place following highest quality standards

**SPECIFIC ASSIGNMENTS/PRIMARY ACTIVITIES**:

- Management of Quality Technical Agreements

Support the supervisor in ensuring the implementation of Quality Agreement with the supplier in compliance with current regulations (laws, European and international GMP standards and company standards).
- CAPA and follow up of required actions

Support the team ensuring the definition of actions to adapt to customer requests, through the verification of consistency with current regulations, the definition of responsibilities and times for carrying out corrective actions, the activation of the functions concerned and the supervision of compliance with the times and requirements defined, in order to allow the regular performance of the activities regulated by the GMP, of the customers' indications
- Deviation, CAPA and complaints management
- Continuous Improvement

Participates, in collaboration with the Production Department and the PPI Team, in the continuous improvement of the Department, providing support in the implementation of new flows, in the optimization of procedures or in the creation of PPI Tools.
- Training and SOPs

This person would support the Team in updating the SOPs concerning the area of competence, through the drafting of the vital documentation, according to the needs and in accordance with the GMP requirements in force.

**Environmental Health & Safety**

Ensure for the Quality mRNA area the acknowledgement and respect for safety conditions, in compliance with laws in force and company policies.

**RELATIONS and INTERFACES**:

- All company functions at all levels
- Other Patheon production sites
- Engineering, Quality Control, Quality system
- Clients
- Supplier

**REQUIREMENTS AND QUALIFICATIONS**:
**Education**:

- Scientific degree (FCT, Pharmacy, Chemistry, Biotechnology, Biology)

**Technical skills**:

- cGMP
- Knowledge of Quality System / Quality Compliance
- Regulatory knowledge
- Familiar with US FDA and EU guidelines
- Knowledge of risk assessment concepts
- Root cause analysis tools
- Lean concepts

**Professional experiences**:

- Experience in Quality/compliance departments in pharmaceutical companies
- Experience in Production

**Languages knowledge**:

- English language skills
- Italian is a plus

**Personality Traits**:
Strong interest in the project and willingness to provide additional value to the team is crucial.
- Steadiness
- Leadership
- Negotiation skills
- Organizational and interpresonal skills

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