SAP / Quality Coordinator (f/m/d)

SAP / Quality Coordinator (f/m/d) – Project Management / GMP / Quality Systems / Quality assurance / SAP-ERP / Communication skills / presentation skills / English and German

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly SAP / Quality Coordinator (f/m/d).

Background:

IMP Quality Operations Switzerland is responsible for delivering Investigational MedicinalProducts („IMPs“) to our patients in compliance with cGMP. We are the Quality Partner for allManufacturing Units and Clinical Packaging in Pharmaceutical Technical Development inSwitzerland and responsible for the Quality and Compliance oversight of all. We are committedto transform ourselves from the inside out towards a purpose driven organization based on strength and role based working. We do this in order to c reate a great place to work, so each of us can thrive and to unleash our full potential.

With ASPIRE, we as an organisation are undertaking the most comprehensive process and digital transformation of its kind in the Biotech industry. By connecting everyo ne in the organisation with the data they need, when they need it, we are removing barriers, burdens and error while creating the digital backbone for Roche`s contribution to people’s health. The SAP / Quality Coordinator role is the main functional contac t (MFC) for IMP Quality Switzerland Clinical

Packaging in the workstream and is empowered to speak on behalf of the function and represents the workstream’s subject matter experts (SMEs) in interaction with the ASPIRE Core Workstream. The role has the over all accountability for the successful regional / local deployment of their respective functional area. Responsibilities include a wide range ofdeliverables of activities commencing with local Fit Gap preparation and culminating withcutover / ramp up / de mobilisation. Candidates benefit from extensive development potentialthrough positioning at multiple interfaces and a fast moving and constantly changingenvironment in which initiative is encouraged and sought.

The perfect candidate: The perfect candidate has experience with SAP implementation projects as well as in the quality field within a global environment in the pharmaceutical industry. SAP ERP experience is a must.The candidate could have worked as a project lead or in a matrix leadership role, leadership

experience is not required.

Tasks & Responsibilities:

Coordination of functional work stream and SME activities:

• Actively participate in the local ASPIRE team meetings led by the Site Deployment Lead and

inform the Team members on current activities in the respective workstream

• Lead the local fit gap for their function and be accountabl e for maximising Template adoption

and minimising localisation or developments

• Responsible for ensuring Quality / GMP Compliance in close collaboration with SMEs and

meeting ASPIRE needs.

Testing preparation and support data migration / cutover:

• Dev elop business case / user requirements for any localisations
• Responsible for helping to organise Site Localisation / Site UAT / Site System Readiness / Site

Preparation, Training, SOP in their respective workstream

• Consulted on Design & Review Technica l Specifications
• Provide functional leadership and content knowledge for data cleansing and data
• Participate in data cleansing and data migration, mapping, transformation and defect

resolution.

• Consulted on User Acceptance Test cases and e xecution of UATs

Run Local SMEs network as required for the functional workstream

• Responsible for successful implementation, actively contributing to Change Impact

Assessments, System Impact Assessments, remediation actions, training etc.

• Coordinate the relevant local SOP assessments and subsequent retire / update

Embrace the change and act as a change agent for the functional workstream to ensure

successful implementation

Must Haves:

• Background in Project Management / Pharma / Quality / IT wi th a Master degree preferred
• Min. 5 years experience working within a global environment in the pharmaceutical industry

and have excellent knowledge of the regulatory requirements surrounding this field, particularly

GMP

• Min. 3 years of experience working with SAP ERP
• Experience in GMP / Quality Systems / Quality assurance
• Demonstrated delivery focus and execution
• Experience with the implementation of large scale projects a plus
• Able to prioritise, quickly establish rapport, and achieve results through others within the organisation.
• Able to lead without direct authority, superior problem solving skills, strong time and self-management skills, outstanding facilitation and presentation skills and excellent written and management skills, outstanding facilitation and presentation skills and excellent written and verbal communication skills
• Able to rapidly analyse data and identify issues and risks
• Good knowledge of cultural differences and the impact of this on communication and working styles
• Fluent in both English and German (written & spoken)
  

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Reference Nr.: 923069SDA
Role: SAP / Quality Coordinator (f/m/d)

Industrie: Pharma
Workplace: Kaiseraugst
Pensum: 80 – 100%

Start: 01.01.2024
Duration: 12++
Deadline: 11.12.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.