This is a remoteposition.
PSCBiotech provides the life sciences with essential services toensure that health care products are developed manufactured anddistributed to the highest standards in compliance with allapplicable regulatoryrequirements.
Ourgoal is to skyrocket our clients success and you can be a part ofour team s achievements. Employing a global team of skilledprofessionals and experts that span across strategically locatedoffices in North America Europe Asia and the Middle East we areproud of the roles we have fulfilled to help our clients achievesuccess.
TheExperience
Withoperations spanning the globe and featuring a multicultural teamPSC Biotech® is passionate about bringing the best andbrightest together in an effort to form something truly special.
When you make the decision to join our team you will be offered theability to feel inspired in your career explore your professionalpassions and work alongside a group of people who will value andnurture yourtalents.
Weare firm believers in coaching and developing the next generationof industry leaders and influencers. As such you will not only beoffered compensation and benefits structure that rewards you butalso be provided with the tools that will help you grow andlearn.
AtPSC Biotech® it s about more than just a job it s aboutyour career and yourfuture.
YourRole
- Administerand maintain the document control system (e.g. Veeva Quality Docs)to ensure all documents (SOPs work instructions quality manuals)are uptodate compliant and properlymanaged.
- Supervisethe creation review approval revision and archiving of controlleddocuments in line with company policies and regulatorystandards.
- Ensuredocument version control and manage regular reviews of controlleddocuments.
- Collaboratewith various departments to ensure timely updates revisions andapprovals ofdocuments.
- Overseethe training program to ensure all employees receive necessary GxPand SOPrelatedtraining.
- Monitorand document employee training records ensuring all trainingactivities are completed and accessible for audits orinspections.
- Maintaincompliance with regulatory requirements by keeping training recordsaccurate anduptodate.
- Preparetraining records and document control systems for regulatoryinspections internal audits and customeraudits.
- Providedocuments and training records for audits and inspections asneeded.
- Workclosely with other functional areas to ensure smooth integration ofdocument control and training activities into dailyoperations.
- Supportcrossfunctional teams by offering expertise on documentationpractices and trainingrequirements.
Requirements
- 23 yearsof experience in document control and / or training roles within aGxPregulated environment (such as pharmaceutical biotech or medicaldeviceindustries).
- Proficientin using document control systems (e.g. electronic documentmanagement systems QMS) and training platforms with a preferencefor experience in Veeva Quality Docs and ComplianceWiresystems.
- Wellversedin GxP regulations (GMP GLP GCP) ISO standards and regulatorycompliance.
- Exceptionalorganizational and time managementabilities.
- Keenattention to detail with the capability to handle multiple taskssimultaneously.
- Strongcommunication and interpersonal skills for effectivecrossdepartmentalcoordination.
- Skilledin using document management software and learning managementsystems(LMS).
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