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!