Senior Quality Systems Specialist

hace 1 semana

Girona, Gerona, España PharmEng Technology A tiempo completo

Efor Group (PharmEng Technology) is seeking a highly experienced Senior Quality Systems Specialist with a strong background in Commissioning, Qualification, and Validation (CQV) to join our team in Girona, Spain. This is a full-time, temporary to permanent with opportunities for growth and development within our growing company.

As a Senior Quality Systems Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical manufacturing processes. You will be for reviewing qualification protocols and ensure its execution is properly completed, meeting the company`s procedures, and processes to meet regulatory requirements and industry standards. This may include overseeing the commissioning, qualification, and validation of equipment, facilities, and processes to ensure they meet quality and performance standard. Experience in Granulation Lines is a plus.

Key responsibilities of this role include:

- Experience in systems like VEEVA is a plus but not mandatory.

- Experience in supporting and preparation for Healthy Authorities inspection

- Develop and maintain quality systems and procedures in compliance with regulatory requirements and industry standards

- Oversee the commissioning, qualification, and validation of equipment, facilities, and processes

- Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

- Review and approve validation documentation, ensuring accuracy and completeness

- Conduct risk assessments and develop risk mitigation strategies

- Lead investigations and root cause analysis for deviations and non-conformances

- Develop and implement corrective and preventive actions (CAPAs) to address quality issues

- Train and mentor junior quality systems specialists on validation processes and procedures

- Collaborate with cross-functional teams to ensure compliance with quality standards and regulations

- Stay current with industry trends and regulatory changes related to CQV and quality systems

Qualifications:

- Bachelor's degree in a scientific or engineering field

- Minimum of 5 years of experience in a pharmaceutical or biotech quality role, with a focus on CQV

- Strong knowledge of regulatory requirements and industry standards, including FDA, EMA, AEMPS, and ICH guidelines

- Experience with commissioning, qualification, and validation of equipment, facilities, and processes

- Excellent problem-solving and analytical skills

- Strong attention to detail and ability to work in a fast-paced, dynamic environment

- Excellent communication and interpersonal skills

- Fluency in English and Spanish, both written and verbal

At Efor Group (PharmEng Technology), we are committed to providing our clients with the highest quality services and solutions. As a Senior Quality Systems Specialist, you will play a crucial role in upholding this commitment and ensuring the success of our projects. If you are a motivated and experienced professional with a strong background in CQV, we encourage you to apply for this exciting opportunity.

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