QA Scientist for Gmp

hace 2 semanas

España Kymos A tiempo completo

We are hiring a Quality Assurance Scientist for our GMP area of Quality Assurance Department.

The QA Scientist will be assigned the following responsibilities:

- Review and approve the documentation involved in the analytical activity of the company: CoA, protocols, reports, SOPs, product specifications.
- Auditing the analytical documentation issued by the operative area to ensure the compliance to the internal and external standards according to cGMP regulations.
- Participate in the QA Annual Program of self-inspections.
- Verify the conformity of quality controls established in the company’s processes.
- Participate in the evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls.
- Review of the Quality/Technical Agreements between the company and subcontractors, especially with regard to batch certification activities.
- Collaborate in audits carried out by our clients or subcontracted manufacturers and give support in the Inspections of regulatory authorities.
- Participate in the implementation and improvement of the quality of the company and subcontractors.

**Requirements**:

- A high level of English, both written and spoken is required for this position.

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