|Beschreibung: || 5478 Compliance Specialist
|Stadt: ||Luzern |
|Firma: ||Computer Futures - London & S.E( - Firma bewerten
|Datum: ||2017-11-22 |
Beschäftigung: bis 100% -
Salär: zu verhandeln CHF -
I am searching for a Compliance Specialist to join my client's team in Lucerne, Switzerland. This is a 9 month contract role with a possibility for extension.
Working with the SCM Quality & Compliance team, the SCM EMEA QMS Coordinator is responsible for all aspects of Documentation, Standard Procedure and Training administration and related systems (eg myLearning, MIDAS). As the organization finds better ways to operate the business it is important to ensure documentation is current and up to date, and that records are held and controlled to meet QMS requirements.
The SCM EMEA QMS Coordinator can guide through some specific elements of GxP, SOP and Quality operational questions for regional SCM personnel and assure the development of the appropriate Training materials, to educate, and train new and existing staff. Provide training in Lean Six Sigma Yellow Belt, GxP elements and procedures, create awareness. Defining the Knowledge Management environment to establish standard way of capturing, storing and archiving SCM formal documents (like Procedures, Standards, Workflows, and RACI's).
Cross functional collaboration with internal stakeholders of all EMEA Hub area's as well as Regional Data CoE, Sales and Regulatory Affairs offices, Franchise, Finance, Shared Business Services, Regional and Sites Quality and Document Centers, Distribution & Logistics, Transportation, Warehouse and Inventory is very important and to be actively supported.
Primary activities include, but are not limited to:
- Serve as point of contact for all SCM EMEA Hub training, work with business to coordinate and schedule required training curricula and training topics.
- Responsible to keep the SOP on Training Management and supportive documents up to date with regards to current regulations, Merck Quality Manual and current practices.
- Monitor Training KPIs and publish department training metrics for follow up and visibility in the Quality Council.
- Ensure timely notification of employees when Standard Processes are moved from "Approved" to "Effective" status.
- Ensure department employees are trained on the most current revision prior to task assignment.
- Coordinate equipment training for department employees (ie schedule, assign Trainer, process training documentation, etc).
- Liaise with the Global Learning & Development Team to ensure global learning standards are met
- Enter Department Training Rosters into site Learning Management System.
- Maintain employee training Matrix and training files.
- Develop and maintain department specific training materials (questionnaires, skill assessments, presentations, etc).
- Helps and reviews Training protocols for new hires from completeness perspective.
- Provide COMET System access to employees based on Training protocol completion.
- Organize and conduct Six Sigma Yellow Belt Trainings based on department need. Hand out certificates to Yellow Belt Graduates.
- Set up and maintain QMS Team Site with relevant folders on SOPs, COMET, Work Instructions etc.
- Compile together with the SCM Quality & Compliance team the Annual GMP Training Plan, based on training needs arising from the implementation of new Hub GxP related procedures, analysis of audit findings, trending analysis of deviations, guidance received from the Hub Quality Council, mandatory Divisional GMP/GDP courses, and Business needs.
- Maintain a training Matrix for all policies, procedures and SOPs versus positions across the Hub, updating it due to new procedures being implemented, or when training requirements are updated, or when procedures are made obsolete.
- Provide assistance to the hub management on GxP training issues and queries.
- Investigate, coordinate and handle any general deviations, complaints, claims or issues in coordination with all impacted stakeholders according to the available SOP's, Policies and Procedures and support any Corrective and Preventive Actions (CAPAs) and initiate and/or establish CAPAs for the role area of responsibility.
- Professional education and skills
- Diploma, Associate or Bachelor's degree in a related technical/business discipline preferred.
- Demonstrated ability to work accurately, meet schedules and timelines, and handle multiple priorities.
- Must be able to work in a team environment and adapt to changing business needs.
- Strong computer skills in Microsoft Office applications.
- Strong technical writing and verbal communication skills, excellent organizational skills.
- Strong attention to detail, critical thinking, and analysis skills (to identify areas for improvement).
- Complete fluency in English
- Project management and organizational skills
- Six Sigma Certification
- Experience in Quality Management Systems and related electronic systems
- Knowledge in GDP/GMP requirements is a plus
- Familiarity with E-learning content authoring tools/development technologies (eg, Articulate)
SThree are committed to ensuring equal opportunities, fairness of treatment, dignity, work-life balance and the elimination of all forms of discrimination in the workplace for all staff and job applicants. We welcome applications from all suitably qualified persons, regardless of their race, sex, disability, religion/belief, sexual orientation or age.