QA Technician: GMP Compliance, PQRs & Change Controls

Chemo; León; On-site; EUR 36,000 - 48,000; Full time

Job summary

Chemo is seeking a Quality Assurance professional to assure GMP, regulatory and internal standards compliance across the site. The role involves CAPA management, PQR support, change controls, cleaning and process validations, and collaboration with customers and authorities.

The candidate should have a degree in Pharmacy, Chemistry or Sciences, strong English and Spanish proficiency, and at least 3 years in a similar role with solid GMP knowledge.

Qualifications

• 3+ years of experience in a similar position.
• Intermediate or high level of English, bilingual with Spanish.
• Knowledge of EU & US GMPs and quality systems (CAPAs, PQRs, audits, validations, change controls).

Responsibilities

• Assure compliance with GMP, regulatory and internal standards per quality policies.
• Develop and review SOPs to ensure regulatory compliance.
• Manage GMP documentation and archive; close CAPAs.
• Support audits, inspections, PQRs, change controls and validations.
• Assist qualified person and coordinate self-inspections and annual training.

Skills

GMP knowledge

CAPA systems

PQRs handling

Education

Degree in Pharmacy or Chemistry or Sciences

Job description

Chemo is seeking a Quality Assurance professional to assure GMP, regulatory and internal standards compliance across the site. The role involves CAPA management, PQR support, change controls, cleaning and process validations, and collaboration with customers and authorities.

The candidate should have a degree in Pharmacy, Chemistry or Sciences, strong English and Spanish proficiency, and at least 3 years in a similar role with solid GMP knowledge.