Técnico QA (PQRs & CCs)

Chemo; Castilla y León; Presencial; EUR 35.000 - 52.000; Jornada completa

Descripción de la vacante

Chemo in Spain seeks a Quality Assurance professional to assure GMP/regulatory compliance and actively participate in CAPAs, PQRs, change controls, and validations across the site. You will review and approve SOPs and maintain GMP documentation.

Requirements include a degree in Pharmacy, Chemistry, or Sciences, 3+ years in a similar role, and English proficiency with Spanish bilingual skills. Knowledge of EU and US GMPs and the ability to support audits and training programs are essential.

Formación

• Degree in Pharmacy, Chemistry or Sciences.
• English and Spanish language proficiency at intermediate/high level.
• Minimum 3 years in a GMP/regulatory role.
• Knowledge of EU and US GMPs and quality systems.

Responsabilidades

• Develop and maintain SOPs to ensure compliance with internal and external regulations.
• Review and approve internal SOPs.
• Manage GMP documentation and archive.
• Register, follow up and close CAPAs per plan.
• Support external audits and inspections according to the Annual Plan.
• Assist the qualified person and support quality activities; conduct self-inspections.

Conocimientos

GMP compliance

CAPA management

PQRs

Change controls

Validations

SOPs management

Documentation control

Educación

Degree in Pharmacy or Chemistry or Sciences

Descripción del empleo

Global Responsibility

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.

· Management of GMP documentations and related archive.

· 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.

· Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.

· 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.