Description
Compliance QA Specialist - German, GMP contract opportunity to join our Neuchatel based client in the Pharma sector.
Your tasks:
Your experience/knowledge:
Your soft skills:
Location:
Zurich, Switzerland
Work setting:
Hybrid
Sector:
Pharma
Start:
Duration:
8+ months
Workload:
100%
Ref.Nr.:
BH 23023
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
Your tasks:
- Execution of all daily QMS activities such as but not limited to:
- Work in a cross-functional team to ensure all quality master data under RP responsibility
- Support mapping required GxP activities to be migrated as part of the integration activities of the Swiss Principal
- Write, review and approve SOPs as required
- Implementation, execution and administration of change controls, deviations and CAPAs
- Ensure that accurare record, as required by the individual elements of the QMS, are kept and maintained in a secure manner.
- Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of Takeda trading licenses and local regulatory requirements.
- Key interactions with global and regional stakeholders including Supply Chain, BPR-I IT team, Legal, Tax, BU's, Quality. Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance to the respective trading licenses.
- Key interactions with numerous stakeholders in Quality (TE RP, OpU quality, Plant and Regional Quality, External Supply Quality)
Your experience/knowledge:
- Good Knowledge of Swiss healthcare legislation, GXP regulations and industry standards.
- GDP, distribution, warehousing and transportation experience or proven equivalent experience
- Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
- Previous experience as RP preferred- GDP, distribution, warehousing and transportation experience or proven equivalent experience
- Good knowledge of SAP system and experience in data migration and/or integration of quality management system activities
- Scientific Degree
- Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.
- German speaking person, ideally German native speaker
Your soft skills:
-
Excellent comprehension skills with attention to detail -
A high degree of self-organisation and time management -
Analytical and solution-orientated thinking
Location:
Zurich, Switzerland
Work setting:
Hybrid
Sector:
Pharma
Start:
Duration:
8+ months
Workload:
100%
Ref.Nr.:
BH 23023
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.