JOB OPPORTUNITIES
(Senior) QA Manager
As a (Senior) QA Manager, you will contribute to the QA team, mainly at the Basel site, and report to the Head of QA.
Key Responsibilities
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Maintain and develop the PQS to ensure GMP/GDP compliance with the requirements for APIs, intermediates, and finished products manufactured by CMOs
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Act as a point of contact for internal and external questions regarding QA
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Review batch documentation in preparation for batch releases
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Review and evaluate Complaints, Deviations, OOS, Changes, etc.
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Review and compile PQRs
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Review and compile Quality Agreements
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Act as QA contact partner for external suppliers
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Plan, execute, and evaluate internal and external audits
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Implement and maintain current GMP/GDP guidelines
Your Profile
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Pharmacist or related scientific background
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10-20 years of professional experience in QA / QC or pharmaceutical production
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Excellent knowledge of QA and GMP / GDP guidelines
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Solid experience as an internal or external auditor
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Committed, initiative, and responsible personality
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Team-oriented, communicative, and diplomatically assertive
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Experience in the handling of narcotics is an asset
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Fluent in German and English is mandatory
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Willingness to travel max. 10%
We Offer
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A position in a successful, fast-growing company
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A dynamic and ambitious environment with very diversified tasks
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The opportunity to create and build up new processes
Regulatory Affairs Operations Manager
As a RA Operations Manager, contribute to the filings of administrative, medical-scientific, and technical changes, as well as renewals and new registrations to health authorities worldwide (EU/CH, Africa, MENA, SE-Asia).
Key Responsibilities
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Responsible for all regulatory relevant electronic systems and databases
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Implement regulatory tracking software, develop processes for maintaining and uploading
IDMP/SPOR data according to current regulatory requirements, and ensure IDMP readiness for CPs
and national registrations
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Coordinate, compile & publish all components of regulatory submission (e.g. eCTDs for new
submissions, variation and/or renewals)
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Ensure appropriate quality control and full technical and regulatory compliance of published output
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Carry out submissions through the relevant portals (e.g., EMA submission gateway, CESP, IRIS)
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Archive final documents/data package electronically according to the internal best practice
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Manage and/or assist with software validation, testing of new releases and new applications, and
support system implementation
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Generate policies and/or internal working instructions on using the departmental regulatory
systems
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Provide training to others on software tools and publishing systems used
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Keep abreast of applicable current regulatory operations environment: communicate guidelines,
requirements, and regulatory documents of interest
Your Profile
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Degree in Science (e.g., Pharmacy, Chemistry, or Biology) or equal level achieved during years of working experience
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Minimum of 5 years of experience in regulatory affairs and a proven history in managing different regulatory operation tasks
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Broad understanding & working knowledge of electronic document and submission standards and requirements applicable to EU, CH, and global regulatory environments
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Critical understanding of the regulatory landscape within the EU
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A first experience in other regulatory affairs areas is a plus
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Excellent communication and organization skills
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Fluent in English - good command of German or French is desirable
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Excellent knowledge of MS Office applications
We Offer
- A position in a successful, fast-growing company
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A dynamic and ambitious environment with very diversified tasks
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The opportunity to create and build up new processes
Ready to take up a new challenge?
Then please send your application to: jobs@eumedica.ch.
Please note that we will only contact short-listed candidates. We are looking forward to meeting you soon!