Chef de Partie (m/w) 100%

Regulatory & Quality Assurance Expert 100% - Stellenbeschreibung 457777

Stelleninserat von Hölzle, Buri & Partner Consulting

09.08.2022 / Arbeitsort: Zug


Telefon: 041 727 67 87
Jobs in Zug


Zur Stelle:

To complete the Regulatory & Quality Assurance department of a pharmaceutical company based in Canton du Zug, we are looking for a Regulatory & Quality Assurance Expert 100%.


Stellenbeschreibung

Execute CH regulatory submissions for existing portfolio and new product acquisitions. Supporting function for maintaining the Quality Management System. Supports Pharmacovigilance processes. Liaises with HQ Regulatory Affairs Team and with other internal and external stakeholders. Interface between the departments of R&D, Market Access, Logistics and Marketing & Sales.

- Preparation, submission and tracing of Market Authorisation(MA) dossiers (all kind of variations, labelling - and, safety updates).

- Evaluation of variations.

- Communication with authority.

- Plans and controls dossier filling process (e.g. Marketing Authorization, Renewals, Amendments of existing MAs).

- Review / approve labelling: Information for professionals and patients, packaging material.

- Supports to maintain and improve a local quality assurance system in accordance with Swiss legislation and good distribution practice (GDP).

- Assists in the development and implementation of SOPs.

- Supports pharmacovigilance obligations for the affiliate in accordance to Art 59 HMG and Art. 60-66 VAM (Date 01.01.2019) and good vigilance practice (GVP). Warrants the compliance with the company quality standards as well as the interaction with and support of the QPPV.

- Support during audits and inspections.

Qualification - Key Requirements / Knowledge

- Bachelor’s degree in pharmaceutical, medical science or equivalent.

- Record of experience in pharmaceutical industry for at least 1 – 2 years.

- Demonstrated understanding of regulatory and compliance guidelines (GDP, GVP).

- native speaker German, business fluent in English.

- MS Office requirements.

Personal Competencies

- Team-player but also able to work independently.

- Deadline driven, strong sense of urgency and commitment.

- Effective planning, organizational and interpersonal skills.

- Able to manage time effectively.

- High quality focus.

- Able to work precisely and dedicated.

- Innovative and active personality with a global view.

If you are interested to join this team please send your application to the attention of Walter P. Hölzle who will handle it with full confidentiality.


Antrittsdatum

Nach Vereinbarung


Ausbildung / Erfahrung

Hochschulabsolventen


Kontakt / Ansprechpartner

Hölzle, Buri & Partner Consulting
Baarerstrasse 2
6300 Zug

Diese Stelle betreut: Walter P. Hölzle
041 727 67 87
Mail


Website

Region(en)

Zug

Schweiz / Kanton Zug


Branche(n) / Rubrik

Chemie / Pharma / Kunststoff / Lebensmittelindustrie / Diagnostics - Regulatory / Regulatory Affairs Manager / Regulatory Affairs Officer


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