Senior Quality Validation Specialist
As Senior Quality Validation Specialist you perform qualification / validation activities in laboratory and manufacturing areas, including facility and utilities, equipment and computerized systems. You prepare and implement the validation documentation required to assure the proper development of a project and manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon
- Prepare and implement the validation documentation required to assure the proper development of a project.
- Act as a validation SME (subject matter expert) for projects, in areas of facility and utilities, equipment and computerized systems:
- Define and implement all validation activities related to the project;
- Develop the Validation Plans: define validation methodology and approach;
- Provide validation expertise for the development of the project;
- Conduct the risk assessment related to the project;
- Review the URS (user requirement specification), FS (functional specification), DS (design specification) and DR (design review);
- Prepare the DQ (design qualification);
- Review the commissioning protocols and reports to ensure leveraging into qualification;
- Prepare the IQ (installation qualification), OQ (operational qualification) & PQ (performance qualification) protocols;
- Assure requirements traceability throughout the whole project validation file (from URS to PQ);
- Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments;
- Analyse, interpret, document and report the testing results;
- Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
- Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system.
- Ensure the correct application of the validation quality systems on the field and to define improvement plan.
- Support the production & technical services teams in the implementation of the validation activities.
- Ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority).
- Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
- Support junior validation specialists as well as provide day-to-day guidance for the execution of Validation activities.
- Coordinate activities of personnel in within the department, in the other departments and contractors.
- Defend validation topics during Regulatory Inspection and prepare validation parts of the submission file.
- Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfilment and EHS
- Contributes to continuous improvement and International standardization for topics related to computerized system, equipment, utilities and facilities.
- Ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up
- Develop and continuously improve expertise linked to the primary validation activities – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions.
- Knowledge of Good Manufacturing Practices guidelines
- Experienced with Quality Management and GxP Regulations
- Knowledge of Validation Methodologies
- Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
- Knowledge of the manufacturing processes
- Excellent analytical skills with systematic approaches to problem solving
- Ability to break down complex problems and tasks into activities capable of being performed by personnel
- Sound industry knowledge, project proficiency, and autonomy
- Strong written and oral communication skills
- Strong organizational and time management skills to carry out multiple assignments
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.