GMP Ops Support
Lieu de travail Visp
Secteurs Autre
Type d'emploi contrat
Un salaire Negotiable
Référence BBBH614079
Description:
Technical role within Manufacturing operations area in charge of managing and/or supporting different gmp relevant type of GMP deliverables for the organization, including, Deviation investigation, CAPAs and CRs. Support the departments of the area to ensure appropriate level of audit readiness and GMP compliance at all times.
Operationally, this includes strict adherence to production and batch release schedule, timely delivery and closure of Deviations, CAPAs, CRs, etc.. while meeting the expected quality of the deliverables
* Provide a safe, controlled work environment in all areas of responsibility
* Work with Stakeholders to ensure cGMP compliance in all aspects of the GMP deliverables under its accountability
* Collaborate with stakeholders and SMEs e.g Ops BPEs, MSAT group, Engineering, QC to bring about process robustness/ improvements to routine manufacturing via CAPA strength
* Responsible for meeting assigned deviation investigations timelines, acting as investigation lead when required, to meet production and batch release schedules while ensuring appropriate level of investigation quality
* Create, review and approve deviation investigation reports, CAPAs etc. to ensure consistency and high standards in technical investigation and writing
* Change request manager for Mfg Operations when designed
* Support on GMP documentation management (review, DMS workflows) of Mfg Operations
* SME from Ops area during audits or customer meetings for the deliverables in scope of accountability
* Interface closely with cross functions department to identify and resolve issues timely
* Any other duties as assigned by your Supervisor/ Manager
Location:
Visp On-site (currently no hybrid possibility)
Education:
Bachelor degree/ Diploma in a Science/ Engineering related discipline in Engineering (Chemical/Biochemical) Science (Biochemistry/Chemistry/ Microbiology)
Languages:
English Business Fluent
Experience and skills:
Preferred at least 5 years cGMP regulated environment, MFG
* Excellent leadership skills in team based management
* Strong communication and interpersonal skills
* Analytical thinking and problem solving skills
* High adaptability in dynamic work environments
* Effective and efficient time management
* Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint)
Competencies and Behaviors:
* Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
* Takes personal responsibility for promoting change in his/her area
* Sets and delivers on individual and team objectives that support the company strategy
* Uses knowledge of his /her business area and related areas to make correct and timely decisions
* Generously shares information and knowledge with others across teams and functions
* Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
Operationally, this includes strict adherence to production and batch release schedule, timely delivery and closure of Deviations, CAPAs, CRs, etc.. while meeting the expected quality of the deliverables
* Provide a safe, controlled work environment in all areas of responsibility
* Work with Stakeholders to ensure cGMP compliance in all aspects of the GMP deliverables under its accountability
* Collaborate with stakeholders and SMEs e.g Ops BPEs, MSAT group, Engineering, QC to bring about process robustness/ improvements to routine manufacturing via CAPA strength
* Responsible for meeting assigned deviation investigations timelines, acting as investigation lead when required, to meet production and batch release schedules while ensuring appropriate level of investigation quality
* Create, review and approve deviation investigation reports, CAPAs etc. to ensure consistency and high standards in technical investigation and writing
* Change request manager for Mfg Operations when designed
* Support on GMP documentation management (review, DMS workflows) of Mfg Operations
* SME from Ops area during audits or customer meetings for the deliverables in scope of accountability
* Interface closely with cross functions department to identify and resolve issues timely
* Any other duties as assigned by your Supervisor/ Manager
Location:
Visp On-site (currently no hybrid possibility)
Education:
Bachelor degree/ Diploma in a Science/ Engineering related discipline in Engineering (Chemical/Biochemical) Science (Biochemistry/Chemistry/ Microbiology)
Languages:
English Business Fluent
Experience and skills:
Preferred at least 5 years cGMP regulated environment, MFG
* Excellent leadership skills in team based management
* Strong communication and interpersonal skills
* Analytical thinking and problem solving skills
* High adaptability in dynamic work environments
* Effective and efficient time management
* Skillful knowledge of Microsoft Windows and Microsoft Office (Excel, Word, Project, PowerPoint)
Competencies and Behaviors:
* Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
* Takes personal responsibility for promoting change in his/her area
* Sets and delivers on individual and team objectives that support the company strategy
* Uses knowledge of his /her business area and related areas to make correct and timely decisions
* Generously shares information and knowledge with others across teams and functions
* Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
Contact: Alba Jansa
Whatsapp: +41 76 811 63 99
alba.jansa(at)experis.ch
