Qa Scientist For Gmp
Hace 3 días
Madrid, España
Kymos-Group
Jornada completa
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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.
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.