Nemensis ag Process governance expert (m/f/x), full-time    Senden

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Standort:	Schweiz, Basel-Stadt, Basel
Datum:	16/03/2020
Branche:	Pharma-Industrie
Bereich:	Forschung und Entwicklung
Niederlassung:	Reinach , Kägenstrasse 18

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For our client, an international pharmaceutical company in Basel, we are in search for a Process Governance Expert (m/f/d) 100%. 

 

What the company offers you:

• You will ensure that different process changes are reviewed, approved and tracked through to completion, including verification of effectiveness


• You will be responsible to ensure procedural documents are appropriately tracked and entered in to the Electronic Standards Operating System (ESOPs)


• Large and diverse infrastructure


• Competitive salary


• 6-month contract with a possibility of extension

 

Your responsibilities:

• Scheduling the meetings, preparing the agenda, tracking and following up on actions and ensuring appropriate completion of effectiveness checks


• Producing metrics to assess the quality of procedural documents and, where deficiencies are identified, supporting with the investigation in to the root cause and initiating corrective and preventative actions (CAPAs) as appropriate


• Tracking all procedural documents for full oversight and inclusion in the Pharmacovigilance System Masterfile


• Preparing cross-divisional guidance documents, training material and communications on process governance standards and change management processes


• Acting as a subject matter expert during inspections (e.g. FDA and EMA) and audits and supporting with post audit/inspection activities including drafting of responses to any findings and the implementation of CAPAs

 

Your profile:

• PharmD, MSc degree in life sciences or equivalent


• Fluency in English. Knowledge of other languages desirable.


• Minimum 2 to 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance


• Excellent organizational skills


• Procedural document writing experience


• Experience of managing activities and projects in a matrix environment

 

Welcome to nemensis!

We look forward to getting to know you!

Your contact person: 

Anastasiya Sakalouskaya | Recruiter
Mail: Anastasiya.Sakalouskaya@nemensis.com

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