Specialist, Quality Systems & Compliance

Job Objective

Review and ensure that products manufactured and released to the market comply with GMP regulations.

This position will initially be located in the Quality Systems department, with responsibilities for Quality Oversight activities of equipment qualifications, and responsibilities for conducting Validations (aseptic simulation, product/process validation, and cleaning validation) during the construction, qualification, and validation phase. The role will transition to the Quality Assurance department upon commencement of commercial production activities.

Role Responsibilities (Initial Phase in Quality Systems)

• Review of documentation for facility and/or equipment qualifications.
• Execution of Validation activities (aseptic simulation, process/product validation, and cleaning).
• Management of Events, CAPAs, and Change Controls (quality member) related to the P5 and P8 vaccine manufacturing and packaging building project for PCX.

Role Responsibilities (Quality Assurance Phase)

• Creation/review/approval of quality-related documentation.
• Quality information management.
• Management of Events, CAPAs, and Change Controls (quality member).
• Quality member in product complaints.
• Support as QA representative in the introduction or transfer of new products.
• Execution of Quality Oversight.
• Creation and maintenance of Quality master data in SAP.
• Specification management.
• Participation in internal, regulatory, and corporate Audits.

Requirements

• Bachelor's degree in Health Sciences (preferably Pharmacy, Master's in Pharmaceutical Industry).
• Relevant professional experience in the pharmaceutical sector.
• Spanish language proficiency.
• Advanced English language proficiency.
• Knowledge of facility and/or equipment qualifications and validations.
• Advanced regulatory knowledge in Good Manufacturing Practices (GMP) and applicable Pharmacopoeias.
• Knowledge of Document Management Systems.
• Advanced knowledge of Quality System tools (change controls, deviation management, out-of-specification results, CAPA management, validations, etc.).
• Data management in SAP.
• Knowledge of biological and sterile product manufacturing processes will be valued.
• Experience in project participation, transfers, and audits will be valued.
• Experience in risk management, statistical tools, and continuous improvement methodologies will be valued.

Key skills/competency

• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• Validation (Process/Cleaning/Aseptic)
• CAPA Management
• Change Control
• Regulatory Compliance
• SAP Data Management
• Auditing
• Product Quality
• Aseptic Manufacturing