QA Technician

hace 2 meses

Guadalajara, España Chemo A tiempo completo

Overview:
Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.

**Responsibilities**:

- Raw material suppliers homologation and sytem maintenance, risk assessment performance. Audits annual plan preparaton and support regarding the audit performance. The role is a contact person of the company regarding quality queries to be managed with raw material suppliers or external services.
- Quality complaints from customers: register, investigation and response. Recurrence and tendency identification.
- PQR preparation according to timelines included in the annual plan, internal procedures and TA in force.
- CAPA and CC system: register, evaluation and follow up. Performance of the specific task assigned to.
- Training: GMP basic training to new staff. Register and follow up.
- SOPs: to prepare or update specific SOP related to the activitivities in charge of.
- Collaborate in external audits from customers and Authorities and conduct shelf
- inspections according to the annual plan.
- Support to Customers and Authorities request for quality and technical issues.

Qualifications:

- **Education**: Degree in Pharmacy or Chemistry or Sciences.
- ** Languages**: Intermediate or high level of English required and bilingual in Spanish.
- ** Experience (years/area)**: A minimum of 3 years’ experience in similar position.
- ** Specific Knowledge**:Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audits support,suupplier managment, change controls, etc.) in pharmaceutical companies. SAP and Trackwise knowledge is valuable.

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