ph3Job Summary /h3 pAssure that all products manufactured at OEM 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 OEM complies with defined standards. Assure the proper implementation of good quality practices in all processes at OEM and be able to identify improvement opportunities necessary to contribute to the robustness of the OEM Quality System. /p h3Key Accountabilities /h3 ul liReview and approval of manufacturing procedures, general procedures or instructions. /li liChange Management: evaluate the impact of the proposed changes, approve action plan proposal and its implementation. /li liValidation/ Qualification: ul liReview of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected. /li liFactory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval. /li liReview of process validations, including validation strategy, execution and management of potential deviations detected. /li liBe able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report). /li /ul /li liRisk Assessment: ul liCarry out, review and approve the risk assessment performed at OEM to evaluate the impact of changes in the final product. /li /ul /li liProvide training in validation risk management to OEM staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies. /li liParticipate in Internal and External Audits as needed. /li liPerform Quality Training to all personnel at OEM. /li liManagement of Non-conformances and CAPA. /li liEnsure that validation lots are appropriately tested,
reviewed and released. /li liImplement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness. /li liBe proactive regarding the continuous improvement in Quality processes and procedures. /li /ul h3Networking/Key relationships /h3 pTo be determined based on department needs, to include interactions such as: /p ul liOperations Area /li liRD Area /li /ul h3Minimum Knowledge Experience required for the position /h3 ul liEducation: ul liRequired: Bachelor's degree (Licenciatura) in any related area Biotechnology, other Sciences, or related field. /li liDegree may be substituted by relevant skills and work experience. /li liValuable: Any additional degree higher than that required previously. /li /ul /li liExperience: Minimum of 3 years in a similar position. /li liAdditional Skills/Knowledge: ul liSoftware: Fluency in Office Tools (Excel Word), Valuable Basic knowledge in SAP. /li liLanguage: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking). /li liStandards: Knowledge of Quality standards /li /ul /li /ul pManagement has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirements. /p h3Skills Capabilities /h3 ul liManagement of decisions under pressure. /li liMethodical and well-organized person. /li liTeamwork. /li liTime management skills. /li liAbility to express information clearly and concisely to the staff, ensuring their understanding. /li liAbility to apply a systematic approach and constant control, follow-up and verification of the results. /li liAbility to collaborate, participate and coordinate actively with working group. /li liReflects values of Werfen in the quality of work and working relationship. /li /ul h3Travel requirements /h3 pNot required. /p /p #J-18808-Ljbffr