Overview:
Commissioning equipment, facilities and utilities. Generation of qualifications protocols and reports. Maintain the correct state of qualification and calibration of the equipment, facilities and utilities. The mentioned equipment, facilities and utilities correspond to the production and R&D; ones.
**Responsibilities**:
- Participate in the acquisition of new equipment, utilities and facilities and review/approve the documentation (URS, supplier documentation) associated to these activities when the work is done by internal or external personnel to the plant in order to check the proper execution and completion of a job.
- Generate the qualification documents (DQ, IQ, OQ and PQ) of equipment (production and R&D;) and facilities, utilities (HVAC, Purified Water, compressed air and nitrogen) when the work is done by internal personnel.
- Perform/coordinate, when applicable, the execution of the qualification activities (run test) and lead any deviation generated during these activities.
- Generate the validation master plan associated to the qualification activities, and the corresponding calibration plan.
- Plan, schedule and coordinate qualifications and calibration activities associated to the corresponding plans to maintain throughout the year validation and calibration status.
- Inventory of computerized systems validation and keep a database current and complete.
- Inventory of equipment, utilities and facilities with their qualification and calibration status and keep a database current and complete.
- Define the required qualification activities when change controls are defined and generate the corresponding documentation (protocols, risk analysis, risk assessment, reports, evaluation, as necessary) and coordinate the corresponding execution when applicable.
- Approve the investigation (root cause analysis) of deviations related to the utilities and facilities. Define together with the department involved in the investigation the appropriate actions and CAPA’s.
- Warehouse monitoring (humidity/temperature)
- Logbook management for critical instruments
- Knowledge in developing standard operating procedures (general quality and departmental) to ensure that all activities defined comply with regulations and internal and external requirements in each case.
- Support external audits and inspections according to the Annual Plan to assess the quality of the GMP.
Qualifications:
- **Education**: University Degree in Engineering or Pharmacy or similar.
- ** Languages**:Very High level of English and Spanish; Knowledge of other European language is also a plus.
- ** Experience (years/area)**: Essential minimum 2-3 years’ experience in department validations and qualifications, in production plants.
- ** Specific Knowledge**:Knowledge of manufacturing processes, production equipment, facilities and utilities, of pharmaceutical manufacturing plants. Knowledge discrepancies, root cause analysis, definition of CAPAS´s. Trend analysis. Risk analysis knowledge.