Quality Assurance System Lead

Quality Assurance System Lead

Manpower Sa | Cape Town, WC, ZA

Posted 16 days ago

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About the position Pharmaceutical concern are seeking to hire a dynamic, passionate, confident, proactive and meticulous Quality Assurance System Lead to join a goal oriented teamResponsibilities:Manage all Quality systems activities, planning to ensure that department goals are timeouslyOverall responsible for all systems within the PQS (Pharmaceutical Quality systems) including Deviations, CAPAs, Change Controls, Quality Risk Management and, DocMS, Logbook management, Archiving, TrackwiseLeads and participates in QA engagement with external third-party stakeholders (e.g. Pfizer and Sanofi) where Quality systems areReview and lead all discussions around site metrics with the applicants.Responsible for ensuring that site compliance metrics are achieved, and actively participates in driving site compliance.Lead the site management review and ensure that action plans are tracked and implemented.Coordinate and analyze all site metrics appropriate with the PQS and drive continuousProvide technical guidance to QA Systems and site team on the QMSDrive continuous improvement onResponsible to keep up to date with cGMP and Guidelines. Ensure that this is updated within the site library.Ensures that obligations as set out in the Quality agreements are fulfilled during the QMSReview and approve all Deviations, Change controls, Incidents, CAPAs linked to the QualityOversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between the company and auditors.Ensuring that the document control activities are achieved at the required quality levels , within the agreed timeframe.Ensures that scientific rationales, risk assessment and reports are in place to supportLead significant investigations that can impact QualityLead significant risk assessments in accordance with ICH Q9.Responsible for ensuring that the eQMS (Trackwise digital) is effectively maintained, updated to latest cGMP requirements and operational to support site activities.Provide QA technical guidance on key strategicRequirements:At least 5 years' experience in vaccine/ biotech/ sterile or pharmaceutical manufacturing industry.At least 2 years' experience at middle management level in cGMP Pharmaceutical manufacturing or equivalentExperience in quality and regulatory compliance within a cGMP facility.Strong knowledge of Quality Systems implementation andExperience in having faced successful local and international quality audits.Please note only shortlisted candidates will be contacted. Desired Skills:Pharmaceutical experiencequality and regulatory compliancequality systemsManpower is the world's leader in employment and staffing services, with offices in over 80 different countries and territories providing individual service to 2.5 million employees world-wide.Manpower can help your company anticipate and benefit from the changes happening now and next, in the contemporary world of work. Over 60 years of experience in staffing and recruitment, training, HR Services, outsourcing and consulting for all industries...Quality Assurance System Lead