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Pharmaceutical Plant Qualification Specialist

2 mesi fa

Latina, Lazio, Italia VTU A tempo pieno

Pharmaceutical Plant Qualification Specialist (m/f/d)

Possible Work Locations

Various locations

Employment Type

Full-time

As a seasoned Pharmaceutical Plant Qualification Specialist, you will oversee the commissioning and validation processes of pharmaceutical facilities, along with their design aspects. Your role encompasses the technical and organizational management of the entire project lifecycle.


Key Responsibilities

  • Management and execution of projects
  • Development of User Requirement Specifications (URS), System Life Cycle Impact Assessments (SLIA), and Computerized System Life Cycle Impact Assessments (CLIA)
  • Creation of various qualification protocols (IQ/OQ/PQ)
  • Compilation of validation summary reports
  • Development of traceability matrices
  • Conducting risk assessments
  • Commissioning of facilities
  • Validation activities for essential equipment and clean utilities in compliance with GMP regulations
  • Implementation of process design and calculations throughout project phases
  • Preparation of Process Flow Diagrams (PFDs) and Piping and Instrumentation Diagrams (P&IDs)
  • Addressing customer specifications
  • Drafting tender documentation and aligning with suppliers

Candidate Profile

You possess a Diploma or Master’s degree in Process Engineering and have substantial experience in the Pharmaceutical Industry or a process engineering firm, particularly in the pharmaceutical or biotech sectors. You are adept at working autonomously while being part of a professional team.

Our Offer

We provide a diverse range of challenging tasks within a committed team and an outstanding work environment. We encourage proactive engagement, offer flexible working hours, and support both internal and external training opportunities.