Técnico QA (PQRs & CCs) (León)

Global Responsibility

Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs management, support on PQRs, Change Controls, cleaning and process validations, among other tasks of the area. Site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU US GMP compliance.

Specific Responsibilities

• Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
• Review and approved internal SOPs
• Management of GMP documentations and related archive.
• Register, follow up and closing of CAPAs opened in the site.
• Support external audits and inspections according to the Annual Plan to assess the quality of the GMP syst...