Julia Faura

Responsible for ensuring the correct implementation and compliance with GMP and ISO 9001 regulations across various activities and processes within the pharmaceutical laboratory.

Tasks performed under the supervision of the Quality Control Director and Technical Management:

• Management and oversight of the Pharmaceutical Quality System: CAPAs, deviations, complaints, change control, environmental monitoring, microbiological control, risk analysis, supplier qualification, and self-inspections.
• Execution and follow-up of validations related to IT systems, facilities, and processes.
• Implementation of OOS (Out of Specification) procedures in ongoing stability studies.
• Monitoring trends in purified and injectable water systems.
• Document control management: drafting and reviewing of certificates, protocols, stability reports (ongoing), trend analysis, complaints (PQR), SOPs, and regulatory submissions.
• Supervision of manufacturing and packaging guidelines for finished pharmaceutical products (oral liquids and solids, IP/INP injectables, and hormonal products) in compliance with regulatory requirements.
• Delivery of training sessions according to the Training Plan.
• Collaboration in the optimization of production and analytical processes.
• Participation in audit teams during both internal and external audits, as well as inspections by health authorities.
• Provided support to departments such as Maintenance, Occupational Health & Safety (OHS), Production, R&D, Regulatory Affairs, and Export.

Under the supervision of the Technical Management, responsible for ensuring proper implementation and compliance with ISO 17025, ISO 9001, and NFC standards.

Key Responsibilities:

• Planning and coordination of microbiological analyses on water, food, and pharmaceutical and cosmetic products.
• Supervision, identification, analysis, and interpretation of microbiological results.
• Coordination and follow-up of calibrations, qualifications, and validations of equipment, processes, and cleanings.
• Supervision and qualification of staff to ensure compliance with operational and regulatory standards
• Document management: drafting and reviewing SOPs, work instructions, authorizations, certifications, and trend analysis.
• Participation in audit teams for both internal and external inspections by health authorities.
• Support to departments such as Pharmaceutical Laboratory, Chemistry, and Occupational Health & Safety (OHS).
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.

Under the supervision of the Deputy Pharmaceutical Manager and the Head of the Radiopharmaceuticals Unit.

Key Responsibilities:

• Preparation of customized formulations in the hospital's pharmaceutical lab for patients receiving specialized treatment.
• Preparation of parenteral drugs for patients in the ICU and Neonatal Units.
• Oversaw the accurate verification and efficient dispensing of high-volume prescriptions, ensuring compliance with pharmacy regulations and safety protocols.
• Contributed to the development of pharmacy procedures for increased efficiency in daily tasks and activities.