QA Associate –

Introduction

Are you an expert in Quality Management System (QMS)? You are looking for a opportunity where you can continuously improve and maintain a QMS?
Check out this vacancy!

Organization

Q-People

Function

The QA Associate will ensure that all operations with international cGMP regulations in general and Belgian laws are followed. Also assures that the internal company standard, the correct detection, reporting and closure of quality events, changes and other types of quality systems related events.
A little grap of the taks of a QA Associate:

– Participation in Quality Risk Management: assess and evaluate the correctness and completeness risk assessments
– QA Review & Follow up of events (including alarm handling), planned deviations, supplier complaints, OOS, CAPA, change requests
– Execution and participation on QA oversight activities, e.g. Gemba walks
– Review and approval of the blanco batch records and batch related labels
– Perform batch record review & follow-up release of batches
– Prepare Batch Release certificates
– Documentation management: Revision, approval, update, storage, distribution and archiving of procedures (SOPs), quality records and files
– Establish product quality documentation system by writing and updating quality procedures
– Training management:
o Keep training files up to date and inform about training status
o Prepare and give QA trainings
– QA Review of:
o Environmental monitoring activities
o Stability protocols & reports
o Validation protocols & reports
o Operator/process qualification
o Visual inspection qualification
– …

Requirements

– Bachelor degree or Master degree in biomedicine, life sciences, pharmaceutical sciences, chemistry Minimum of 3 years of relevant professional experience in Quality Assurance in pharmaceutical industry
– Knowledge of cGMP requirements and experience in the application and interpretation of cGMP requirements or equivalent e.g. ISO
– Quality focused and eye for detail
– Data management skills, accuracy, punctuality
– Advanced written and verbal communication skills
– Well organized, well-structured, hands-on, result focused
– Good knowledge of English and Dutch
– Good understanding and use of MS Office (Excel, Word, PowerPoint, Outlook)

Offer

Wat mag je van ons verwachten?

– Open en vlakke organisatie met een HR-coach die jou persoonlijk opvolgt en die samen met jou een individueel carrièreplan opstelt.
– Via ons Q-Academy bieden we voor jou een uitgebreid opleidingspakket om continu bij te leren in kennis maar ook in vaardigheden.
– Vast contract met een competitief salarispakket en extralegale voordelen zoals een hybride bedrijfswagen en een tankkaart, netto onkostenvergoeding, groepsverzekering, hospitalisatieverzekering = full DKV, maaltijdcheques (€ 8), 13e maand.

Application

Phyllis Horemans | HR / Talent Manager
[email protected]
Graaf Van Egmontstraat 15/4 | Mechelen

 

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