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 with internal procedures, GMP 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 approve internal SOPs.
* Manage GMP documentation and related archive.
* Register, follow up and close CAPAs opened in the site.
* Support external audits and inspections according to the annual plan to assess the quality of the GMP system.
* Support the qualified person.
* Elaborate and follow up self‑inspections program and conduct self‑inspections.
* Support customers and authorities' requests for quality and technical issues.
* Elaborate and follow up training annual program.
* Collaborate with supplier’s qualification management.
* Prepare PQRs according to timelines included in the annual plan, internal procedures and TA in force.
* Collaborate with change control management.
* Support quality activities according to the appropriate training.
* Conduct validation activities related to manufacturing and cleaning processes.
* Review and approve monitoring of pressures and temperature performed by Engineering, for the different areas of the site.
* Support qualification of equipment and systems for compliance with GMP.
Requirements and personal skills
* Education: Degree in Pharmacy, Chemistry or Sciences.
* Languages: Intermediate or high level of English required and bilingual in Spanish.
* Experience: A minimum of 3 years’ experience in a similar position.
* Specific Knowledge: Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audit support, validations, change controls, etc.) in pharmaceutical companies.
#J-18808-Ljbffr