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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

  • Maintain and develop the PQS to ensure GMP/GDP compliance with the requirements for APIs, intermediates, and finished products manufactured by CMOs

  • Act as a point of contact for internal and external questions regarding QA

  • Review batch documentation in preparation for batch releases

  • Review and evaluate Complaints, Deviations, OOS, Changes, etc.

  • Review and compile PQRs

  • Review and compile Quality Agreements

  • Act as QA contact partner for external suppliers

  • Plan, execute, and evaluate internal and external audits

  • Implement and maintain current GMP/GDP guidelines

Your Profile

  • Pharmacist or related scientific background

  • 10-20 years of professional experience in QA / QC or pharmaceutical production

  • Excellent knowledge of QA and GMP / GDP guidelines

  • Solid experience as an internal or external auditor

  • Committed, initiative, and responsible personality

  • Team-oriented, communicative, and diplomatically assertive

  • Experience in the handling of narcotics is an asset

  • Fluent in German and English is mandatory

  • Willingness to travel max. 10%

We Offer

  • A position in a successful, fast-growing company

  • A dynamic and ambitious environment with very diversified tasks

  • 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

  • Responsible for all regulatory relevant electronic systems and databases

  • 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

  • Coordinate, compile & publish all components of regulatory submission (e.g. eCTDs for new

    submissions, variation and/or renewals)

  • Ensure appropriate quality control and full technical and regulatory compliance of published output

  • Carry out submissions through the relevant portals (e.g., EMA submission gateway, CESP, IRIS)

  • Archive final documents/data package electronically according to the internal best practice

  • Manage and/or assist with software validation, testing of new releases and new applications, and

    support system implementation

  • Generate policies and/or internal working instructions on using the departmental regulatory

    systems

  • Provide training to others on software tools and publishing systems used

  • Keep abreast of applicable current regulatory operations environment: communicate guidelines,

    requirements, and regulatory documents of interest

Your Profile

  • Degree in Science (e.g., Pharmacy, Chemistry, or Biology) or equal level achieved during years of working experience

  • Minimum of 5 years of experience in regulatory affairs and a proven history in managing different regulatory operation tasks

  • Broad understanding & working knowledge of electronic document and submission standards and requirements applicable to EU, CH, and global regulatory environments

  • Critical understanding of the regulatory landscape within the EU

  • A first experience in other regulatory affairs areas is a plus

  • Excellent communication and organization skills

  • Fluent in English - good command of German or French is desirable

  • Excellent knowledge of MS Office applications 

We Offer

  • A position in a successful, fast-growing company
  • A dynamic and ambitious environment with very diversified tasks

  • 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!

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