Técnico QA (PQRs & CCs)

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

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 system.
• Support to the qualified person.
• Elaborate and follow-up self-inspections program and conduct self-inspections.
• Support to Customers and Authorities request for quality and technical issues.
• Elaborate and follow-up training annual program.
• Collaborate with supplier’s qualification management.
• PQR preparation according to timelines included in the annual plan, internal procedures and TA in force.
• Collaborate with Change Control management
• Support to quality activities according to the appropriate training.
• Validation activities related to manufacturing and cleaning processes
• Review and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site.
• Support the qualification of equipments and systems for complying with GMPs.

Requirements and personal skills

• 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, validations, change controls, etc.) in pharmaceutical companies.