Qualification Specialist - Peñalolén

An important company in the pharmaceutical sector is looking for a Qualification Specialist to join a project lasting until December, actively participating in the execution and management of qualification processes for equipment, facilities, critical systems, and computerized systems.

We are looking for professionals with experience in the pharmaceutical industry, attention to detail, management capacity, and solid knowledge of GMP/GxP regulations.

Main functions

• Execute the qualification program for critical support systems, facilities, production equipment, process control instruments, and validation of computerized systems.
• Prepare, analyze, and manage technical documentation associated with manufacturing equipment, critical systems, and control instruments.
• Generate protocols and qualification reports for equipment, facilities, and computerized systems according to the qualification plan.
• Identify, document, and manage deviations, participating in the definition of CAPA actions under GMP and SUPAC guidelines.
• Review FAT and SAT documentation issued by manufacturers and execute tests together with suppliers.
• Coordinate inter-area activities for the timely fulfillment of the qualification plan.
• Execute qualification protocols for facilities, critical support systems, and validation of computerized systems.
• Participate in commissioning activities when required.
• Execute decommissioning activities for equipment, areas, and critical support systems.
• Coordinate with the QC Laboratory for the delivery of samples required for qualifications.
• Supervise and manage external providers associated with the execution of the qualification plan.
• Ensure compliance with Safety, Occupational Health, and Environment (EHS) standards.
• Rigorously comply with ALCOA+ principles, Good Manufacturing Practices (GMP), and GxP guidelines.

Requirements

• Degree in mechanical engineering, chemical engineering, pharmaceutical chemistry, or related fields, with at least 3 years of work experience in the pharmaceutical industry. Previous experience in qualifications and knowledge of production processes is desirable.
• Intermediate Level: GMP standards
• Intermediate English (written, spoken, and reading) with fluency, mastery of technical English associated with qualifications, GMP, and terms associated with validations in the pharmaceutical industry
• Advanced Microsoft Office
• Knowledge of FDA, ICHQ, and Chilean regulatory standards for the qualification of equipment, systems, and facilities.

Offered

• Project lasting until December.
• Salary according to the market.
• Lunch in the company cafeteria.
• Opportunity to participate in an important pharmaceutical company.

Conditions

• Modality: On-site.
• Location: Peñalolén.
• Workday: Artículo 22.
• Fixed-term project until December.

If you have experience in qualifications within the pharmaceutical industry and are looking to join a challenging project in a leading company in the sector, we invite you to apply.

-Requirements-

• Minimum education: High school / Technical education
• 3 years of experience

Keywords: specialist, especialista