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von: Kelly Services (Schweiz) AG | localité: BaselN: KellyServices(Schweiz)AG
We are looking for a new team member as a contractor for our client, the pharmaceutical company F. Hoffmann-La Roche Ltd.
Local QA/Compliance Lead (m/f/d)
Temporary employment, 80 – 100%
Background
The Local QA/Compliance Lead is primarily to ensure appropriate local Aspire activities and deliverables meet QA/Compliance expectations and ensure compliance is maintained. Ultimately, the Local Lead will be accountable for ensuring the site is "inspection ready".
In this role you will work closely with core counterparts to understand the core deliverables and to ensure local compliance efforts are complementary to those produced on behalf of the wider program.
Locally, the Lead will ensure that local change requests, protocols, CSV & Quality deliverables, plans and reports are all completed in alignment with project plans/timelines and to ensure that any compliance risks are mitigated.
Tasks & Responsibilities
- Accountable for local CSV & Quality deliverables defined for the local deployment
- Definition of local change request/validation/implementation plans (incl. CSV) and related closure/reports
- Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
- Coordinate and support adoption of local SOPs triggered by ASPIRE (i.e. definition of the SOP inventory, planning and coordination of SOP updates according to plan)
- Supporting the training activities for ASPIRE
- Supporting test planning, execution, closure and defects
- Supporting data migration, local verification and incidents associated with GxP data
- Supporting local cut-over activities to ensure all protocols are completed and deviations accepted
- Supporting any definition of interim ways of working required during cut-over
- Defining and supporting any PQ activities if required
- Compliance support for defects, incidents and change controls
- Coaching and training of local ASPIRE team as required in related compliance approaches/deliverables
- Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the ASPIRE project
Profile
The perfect candidate has a successfully completed engineering degree in the field of biotechnology, pharmacology or process engineering combined with the necessary specialist knowledge for this activity. The person needs min. 5 years of experience in a GMP regulated manufacturing environment and with validation responsibilities as well as min. 3 years of experience in quality management in the technical and CSV qualification fields. Experience in a matrix leadership role is required.
- Master's degree in engineering in the field of biotechnology, pharmacology or process engineering, combined with the necessary specialist knowledge for this activity
- Min. 5 years of experience in a GMP regulated manufacturing environment and with validation responsibilities
- Min. 3 years of experience in quality management in the technical and CSV qualification fields
- Extensive experience with the regulatory requirements in the GMP environment
- Experience in a matrix leadership role
- Compliance work within a project/change environment (in multi-site/global projects)
- Understanding of ERP life cycle, deliverables and the compliance needs/implications
- Experience in previous deployment of global application to site is highly advantageous
- Fluent both in English and German (written/spoken)
- Excellent communication skills: this role requires clear direction locally, but also will involve global/above site engagement for both straightforward communication, and also influencing
- Very Good x-functional understanding of compliance within a manufacturing site
- Ability to work in a matrix environment. Controlling/developing compliance deliverables and supporting other streams as appropriate
- Ability to understand the nature of risks and promote/support appropriate mitigations
- Coaching/supporting streams
- Ability to influence, especially within a global team environment
- Ability to work within a multicultural environment
General information
- Start date: asap (latest start date: January 2024)
- Duration: 18 months
- Workplace: Basel and Kaiseraugst
- Workload: 80 – 100% (max. 40% remote working is possible)
Your application
If you are interested, please apply online or send your CV to Nicole Blum: nicole.blum[at]kellyservices.ch
If you have any questions in advance, you can also reach Nicole Blum by phone: +41 (0)61 270 80 14 or +41 (0)79 204 36 85
We look forward to hearing from you.
