Compliance QA Specialist/Responsible Person (m/f/d)
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The Compliance QA Specialist/Responsible Person (RP) will be responsible for execution of daily activities associated with implementation and maintenance of the Quality Management Systems and Quality Assurance activities in relation to local Swiss Establishment License.
Duties:
1. Execution of all daily Quality Management Systems activities
2. Ensuring all quality master data is correct
3. Mapping required GxP activities, migrated as part of the integration activities of the Swiss Principal
4. Writing, reviewing, and approving SOPs as required
5. Implementing, executing, and administering change controls, deviations, and CAPAs
6. Accurate recording of all elements of the QMS
7. Supporting Trading Entity Compliance group to ensure related GxP activities which support the global trading of products are compliant and efficient.
8. Ensuring quality management system is implemented and maintained
9. Managing authorized activities and the accuracy of and quality of records
10. Ensuring that relevant customer complaints are dealt with effectively
11. Approving suppliers and customers
12. Responsible for self-inspections
13. Adhering to all additional requirements imposed on certain products by national law
Qualification and experience:
1. Scientific Degree
2. Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug/substance compliance
3. Good knowledge of Swiss healthcare legislation, GXP regulations, and industry standards
4. GDP, distribution, warehousing, and transportation experience or proven equivalent experience
5. Good knowledge of SAP system and experience in data migration and/or integration of quality management system activities
6. Previous experience as Responsible Person preferred - GDP, distribution, warehousing, and transportation experience or proven equivalent experience
7. Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland
8. Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of the trading licenses and local regulatory requirements
9. Experience in having 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 compliance to the respective trading licenses.
10. Fluent in German
Deadline for submissions: Thursday at 11am
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Quality Assurance
* Pharmaceutical Manufacturing and Biotechnology Research
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