two.jobs
QA and RA manager (100%) Finished Dosage Forms Responsible Person (FvP)
Employment type
Full-time
Languages
English, German
Skills
Microsoft Excel
Details zum Jobangebot
For our Client Selectchemie AG we are looking for a QA and RA manager (100%) Finished Dosage Forms Responsible Person (FvP).- Management of a small team.
- Harmonization of quality technical agreements
- CMO and service provider qualification: Perform the initial audit for site qualification. Organize and participate in the re-qualification audits.
- PQR preparation and customization if necessary
- Change management/documentation approval: record and process change applications according to the internal procedures. Communicate required changes with MAHs. Approve internal changes (based on API manufacturer, CMO, customer or internal request).
- Deviation/complaint management: Support handling, responding, tracking of any FDF related deviation and/or complaints being received by any customer or contract partner according to the internal procedure. Ensure good communication between the involved parties (internally and externally). Participate in deviation/complaint investigation to the extent required.
- Batch record review: Review CMO provided batch documentation according to the internal procedure. Request missing documentation and clarification if required. Continue monitoring.
- Documentation management: Review/prepare/approve SOP concerning FDF activities; assess products and CMOs in quality management review; supervise on-going stability program; review and release transport monitoring; release of secondary packaging material specification; release of secondary packaging material for further processing
- Responsible for compliance with GMP/GDP.
- Responsible towards Swiss therapeutic products authorities. Participate in the authority audit.
- Ensure required support for new registrations and timely responses to the questions raised by the health authorities.
- FvP Fachtechnisch verantwortliche Person qualification would be an asset
- University degree in Pharmacy, Chemistry, Biochemistry or Biotechnology
- Good knowledge of EU GMP regulations
- At least 3 years’ working experience in medicinal products’ manufacturing pharmaceutical company, particularly in quality assurance area. Experience in production is of advantage
- Experience in product quality reviews preparation, deviation and change control management, batch record review
- Experience with harmonization of quality technical agreements and supplier auditing
- Good understanding of regulatory requirements
- Experience in managing small team
- Excellent communication, project management, planning, problem solving and presentation skills
- Flexibility to work in a global regulatory cross cultural work environment and ability to work independently as well as in a team
- Fluent in English, German is a plus
- Entrepreneurial position in a dynamic globally acting team
- Your input is key and you’re part of creating our future success
- Close cooperation with colleagues across the entire hierarchy within Selectchemie
- Close cooperation with C(D)MOs, customers/licensees on a global basis
- Short decision processes
- Attractive compensation package and remote working if you are not based in Switzerland
- Up to 40% home office for employees in Switzerland
- Travel of about 20%
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https://www.selectchemie.com/Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full-service provider we create added value by offering comprehensive technical, scientific, regulatory and commercial support all along the value chain. Worldwide, our 120 experienced professionals with commercial and scientific background, based at the headquarters in Zurich, Switzerland and locations in 18 countries, provide customers, principals and suppliers with solutions tailored to their needs.
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