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People Business Partner Werfen Immunoassay
Job Summary
Quality Validations engineer assure that all products manufactured at Immunoassay (IA) are designed, manufactured and released according to established procedures and validated processes. Assure that all facilities, utilities and equipment involved in the production of all products manufactured at IA complies with defined standards. Assure the proper implementation of good quality practices in all processes at IA and be able to identify improvement opportunities necessary to contribute to the robustness of the IA Quality System.
Key Accountabilities
* Review and approval of manufacturing procedures, general procedures or instructions.
* Change Management: evaluate the impact of the proposed changes, approve action plan proposal and its implementation.
* Validation/ Qualification: Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.
* Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.
* Review of process validations, including validation strategy, execution and management of potential deviations detected.
* Be able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report).
* Carry out, review and approve the risk assessment performed at IA to evaluate the impact of changes in the final product.
* Provide training in validation & risk management to IA staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies.
* Participate in Internal and External Audits as needed.
* Perform Quality Training to all personnel at IA.
* Management of Non-conformances and CAPA.
* Ensure that validation lots are appropriately tested, reviewed and released.
* Implement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness.
* Be proactive regarding the continuous improvement in Quality processes and procedures.
Networking
Mainly with Operations Area and R&D Area.
Education
Required: Bachelor's degree (Licenciatura) in any related area Biotechnology, other Sciences, or related field.
Valuable: Any additional degree higher than that required in the previous section
Degree may be substituted by relevant skills and work experience
Experience
Minimum three (3) years in a similar position
Additional Skills
Fluency in Office Tools (Excel & Word), Valuable basic knowledge in SAP
Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading, speaking and writing)
Standards: Knowledge of Quality standards.
Skills & Capabilities:
* Management of decisions under pressure.
* Methodical and well-organized person.
* Teamwork.
* Ability to express information clearly and concisely to the staff, ensuring their understanding.
* Ability to apply a systematic approach and constant control, follow-up and verification of the results.
* Ability to collaborate, participate and coordinate actively with working groups.
* Reflects values of Werfen in the quality of work and working relationship.
Travel
No required
Seniority level
Associate
Employment type
Full-time
Job function
Other
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