QA Equipment Qualification Consultant(100%

hace 2 semanas

Madrid, España Avacone AG A tiempo completo

We are looking for joining AVACONE Projects experts to collaborate in implementing and maintaining relevant projects for our global customers in a multinational environment.

AVACONE takes care of its professionals and always offers them high added value projects and accompanies them in their professional development over time in the acceleration of their careers.

**QA Equipment Qualification Consultant**

Functions:
*Provide QA oversight of commissioning, qualification and validation activities

*Responsible for managing the QA review/approval of design and commissioning documentation, validation plans and protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.

*Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.

*Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.

*Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.

*Support the Project team to ensure the delivered documentation and activities are compliance with internal policies, procedures, guidelines and applicable health authority regulations.

*Support the required activities for GxP readiness, Health authority inspections and Internal audits on request.

*Collaborate within the cross-functional project team to identify efficiencies around maintenance/control of documents in full alignment with the applicable requirements.
- Extensive knowledge in biotechnology. Knowledge of microbiological techniques.

Minimum requirements:
Bachelor’s Degree in Chemistry, Biology, or a related scientific discipline.

2-5 Years experience in the biotechnology/biopharmaceutical industry, or related field.

1-3 Years experience in Quality Assurance and/or Validation in the pharmaceutical industry.

High level of English.

Workload: 100%
Contract: Permanent

Location: Hybrid Job (Madrid)

Excellent working environment

Language: English & spanish

So Interested? Please get in contact with me...

Tipo de puesto: Jornada completa, Contrato indefinido

Horario:

- De lunes a viernes

Posibilidad de trasladarse/mudarse:

- Madrid, Madrid provincia: Desplazarse al trabajo sin problemas o planificar mudarse antes de comenzar a trabajar (Obligatorio)

Fecha de inicio prevista 01/05/2023

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