Global Gxp Quality Manager

hace 4 semanas


Heredia, Costa Rica Bayer A tiempo completo

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.**

**TASKS AND RESPONSIBILITIES**
- Major Tasks Maintenance and coordination of Quality Management Systems (QMS) at Shared Service Center Delivery network. Perform implementation of global SOPs to QMS, based on updates train staff with respective effectiveness check.
- Perform regular cross meetings between SSCDN sites performing to ensure common understanding of QMS.
- Lead 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, Support QAAs preparation and update.
- Ensure the implementation of actions plans are executed in a timely manner.
- Responsible to lead the compilation, analysis and reporting of Quality Metrics (including but not limited to Management Review, KPIs, Quality Board) to detect signals and anticipate potential non conformities and to maintain key performance indicators as per quality objectives.
- Responsible for safeguarding all documents, 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 in paper based as required.

**WHO YOU ARE**
- Bachelor s Degree in Natural Science, Business Administration or Engineering.
- Minimum of 5 years of experience in Quality Management areas. (mandatory).
- Pharma or Medical Device background desired.
- Languages: Spanish: (Native or proficient) Desirable English level: (Native or proficient) (Strong technical writing skills): able to provide general instructions and techniques in another language to the native.
- Required Knowledge: Quality Management Systems. Strong knowledge in Statistical Techniques (DOE,SPC) Project Management, CAPA, Lean Six Sigma, root cause analysis and Failure Analysis. GxP and Data Integrity Requirements. FDA, ISO, euMDR auditing requirements.
- Extensive and strong problem solving, root cause analysis and technical/engineering skills to lead and influence change are considered assets. High level computer knowledge (Excel, Word, E mail, Change Control, Power Point, SAP, Project, Visio, Minitab).
- Internal Quality Auditor. Abilities and skills: Strong leadership, conflict resolution, and negotiation skills required.
- Capable of leading cross functional teams globally. Ability to multi task and make decisions in a fast paced work environment and to self direct,as required. Adaptable and able to face the changes in a positive way. Availability to travel as needed.
- Proactive and self motivated person. Capacity to work under pressure. Good soft skills and emotional intelligence.

**Application Period**:

- 17/02/2023-24/02/2023**Reference Code**:

- 787080**Division**:

- Enabling Functions**Location**:

- Costa Rica : Heredia : Heredia**Functional Area**:

- Quality**Position Grade**:

- VS 1.1**Employment Type**:

- Regular**Work Time**:

- Full Time**Address**
- Heredia, Costa Rica



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