Mrna Quality Operation Specialist

6 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 sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team 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.

mRNA Business Unit is looking for a mRNA Quality Specialist.

Main tasks:
Collaborate with colleagues in supporting all the qualification activities related to the mRNA Facility, in particular:
Deviation management

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

Quality oversight & BRR

Execute the quality oversight during the manufacturing activities and execute the doacumentaion review on batch record ans all the documentation related to compliance status of the department. Encourage the sharing of problems and related corrective actions with the Production Department through periodic huddles.

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).

Training and SOPs

Perform the training of personnel involved in the Quality on the Floor activity and of those operating in the Departments for activities related to their area of competence, in accordance with current company procedures.

Support the Team in updating the SOPs concerning the area of competence, through the drafting of the necessary documentation, according to the needs and in accordance with the GMP requirements in force.

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.

Contribute/lead specific projects/initiatives to improve quality standards and Procedure related to manufacturing activities.

Environmental Health & Safety

Ensure for the Quality mRNA area the acknowledgement and respect for safety conditions, in respect of the laws in force and company policies.
- RELATIONS:
Internal
- All company functions at all levels
- Other Patheon production sites
- Engineering, Quality Control, Quality system, training,

External
- Clients
- Suppliers
- REQUIREMENTS AND QUALIFICATIONS:
ESSENTIALS

**Education**:

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

Technical skills:

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

Professional experiences:

- Experience in Production/Quality/compliance departments in pharmaceutical companies (3 years)

Languages:

- English

Personality Traits:

- Steadiness
- Leadership
- Negotiation skills
- Organizational skills

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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