An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.
Senior QA Validation Specialist – 5459 Cbo
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Validation Specialist for a 6 months contract with possible extension based in the Valais area, Switzerland.
The Senior Validation Specialist performs qualification / validation activities in laboratory and manufacturing areas, including facility and utilities, equipment and computerized systems. He/she prepares and implements the validation documentation required to assure the proper development of a project and manages deviations and changes 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;
- Assure requirements traceability throughout the whole project validation file (to PPQ);
- Organize and coordinate validation activities with the different involved departments;
- Analyze, 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
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job-related discipline
- Minimum 10 years in similar environment
- Control Systems and IT/Quality Control/Validation,.
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing