Job Description

• Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
• Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
• Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
• Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
• Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
• Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
• Other duties may be assigned to this role.

• Educated to a degree level in a technical or natural scientific field.
• Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
• Knowledge of qualification needs to cGMP guidelines.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Familiarity working with cross-department stakeholders.
• Knowledge of quality assurance principles.
• Experience working within project teams and various projects in parallel.
• Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
• Effective communication skills, both verbally and in writing.
• Able to think analytically with the ability to resolve issues.
• Able to manage own time efficiently.
  

• Experience in a GMP environment
• Experience generating C&Q protocols & executing C&Q protocols
  

• Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
• Creating new test methods and the required test fixtures.
• Creating all the required documents for qualification, validation and transfer of test methods.
• Create, revise parts and drawings using CAD software (SolidWorks Preferred).
• Perform data analysis using Minitab and interpret data.
• Performing and operating the tests required for qualification, validation and transfer of the methods.
• Creating training documents.
• Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.