Gxp Quality Sr Expert

Título del trabajo: Gxp Quality Sr Expert

Compañía: Bayer

Descripción de funciones: **GxP Quality Sr Expert** When you show proactivity and ambition, we’ll harness it through a variety of opportunities and challenges in the diverse areas of our business – all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to make a difference? The choice is yours, and we’ll help you get there. **Be better together. Be Bayer.**

**YOUR TASKS AND RESPONSIBILITIES**
– Maintenance and coordination of QMS at Shared Service Center Delivery network.
– Perform implementation of global SOPs to local QMS, based on updates.
– Ensuring quality training system is established and maintained (e.g. GMP / GDP) for the GBS Organization.
– Ensure a suitable Change Management system is in place to keep the QMS compliance status.
– Support regular cross meetings between SSCDN sites to ensure common understanding of QMS.
– Support self-inspection program: Audit Schedule, Documentation, CAPA Follow up, control and report metrics related to KPIs.
– Documentation Control: Oversight of documentation lifecycle, promote the GxPs in the SSCDN, promote coordinated teamwork to achieve Data Integrity Standards.
– Ensure implementation of actions plans is executed in a timely and effective manner.
– Support the compilation, analysis and reporting of Quality Metrics (including but not limited to Management Review, KPIs, Quality Board) to detect signs and anticipate potential nonconformities and to maintain key performance indicators as per quality objectives.
– Identify efficiencies and drive improvements as identified. Identifies gaps related to the Quality Management System and establishes mitigation measures.
– Take responsibility and active role for all new projects including those with GxP relevance.
– Responsible for safeguarding all documents and confidential information.
– Promote continuous improvement by identifying problems and development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.
– Act as approver in documents assigned in LifeDoc and some other quality related documents as required.

**WHO YOU ARE**
– Bachelor s Degree in Engineering, Auditing, Business Administration, Life science or similar.
– At least 3 years of experience in Shared Service centers or quality areas.
– Pharma or Medical Device background desired.
– Advanced English and Spanish level both written and spoken.
– Quality Management Systems. Project Management, Failure Analysis.
– GxP and Data Integrity Requirements. FDA, ISO, euMDR auditing requirements.
– Desirable Extensive and strong problem solving, root cause analysis and technical/engineering skills to lead and influence change are considered assets.
– Internal Quality Auditor.
– Strong leadership, conflict resolution, and negotiation skills required.
– Capable of leading cross functional teams globally.
– Ability to multitask in a fast-paced work environment and to self-direct, as required.
– Adaptable and able to face the changes in a positive way.
– Proactive and self-motivated person.
– Good soft skills and emotional intelligence.
– Ability to meet standards for business and quality.
– Flexibility to assume new roles or responsibilities as required.
– Ability to take decisions based on risk analysis and act in an independent manner.
– Available to travel internationally.

**Application Period**:

– 11/09/2023 – 11/23/2023**Reference Code**:

– 805565**Division**:

– Enabling Functions**Location**:

– Costa Rica : Heredia : Heredia**Functional Area**:

– Quality**Work Time**:

– Full Time**Employment Type**:

– Regular**Contact Us**

**Address**

**E-Mail**
– Heredia, Costa Rica

Ubicación: Heredia

Fecha del trabajo: Tue, 09 Jan 2024 23:37:20 GMT


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