$$$$
{{ $t($store.state.user.experience_value_in_dollars) }}
Expert
{{ $t($store.state.user.experience_search_name) }}
0
jobs
Improving Quality
Mariem Sarghini
,
London, United Kingdom
Experience
Other titles
Skills
I'm offering
A Quality Assurance ('QA') professional with 16 years' experience in QA and 11 years' experience as a Good Clinical Practice ('GCP') Pharmacovigilance (GVP) auditor with pharmaceutical companies, Contract Research Organizations ('CROs') and Pharmacovigilance service provider. With over 5 years QA Management experience across the GXPs.
Markets
United Kingdom
Language
English
Fluently
Ready for
Larger project
Ongoing relation / part-time
Available
My experience
2019 - ?
job
Director Quality Assurance
Bionical Emas.
• Commercialization and business development activities for QA department, attending bid defense meetings, global conferences identifying new business leads for the department.
• Conduct of Internal and supplier Audits, including for cause audits across the GXPs
• Annual risk assessments across the business function to identify the audits to be scheduled in across a 5-year period.
• Management of global audit schedule and ensuring all audits are completed on time and within budget.
• Management of GxP audit consultants
• Gap Analysis of systems, bridging gaps by creation of procedures and training workshops.
• Provision of QA consultation services to both external and internal stakeholders.
• Conduct of Internal and supplier Audits, including for cause audits across the GXPs
• Annual risk assessments across the business function to identify the audits to be scheduled in across a 5-year period.
• Management of global audit schedule and ensuring all audits are completed on time and within budget.
• Management of GxP audit consultants
• Gap Analysis of systems, bridging gaps by creation of procedures and training workshops.
• Provision of QA consultation services to both external and internal stakeholders.
Business development, Training, Budget, Audit, Management, QA, Workshops, Quality Assurance, Development, Audit
2016 - 2018
job
Senior Manager Quality Assurance
APCER Life Science.
• Setting up training programs for audit training
• SOP creation, development implementation and training
• Gap analysis
• Hosting client audits and regulatory inspections
• CAPA Management
• Management and delivery of the global audit program
• Line manager to 5 auditors
• CAPA metric development
• Awareness of current PV and GCP regulations
• Driving due diligence activities for all vendors/sub-contractors used
• Acting as Client Liaison and main point of contact for any quality related issues
• Reviewing and approving deviations and assessing impact to the global PV system
• Leading the quality assurance department as being a department of excellence and a 'go to' place for all quality related issues.
• Commercialization of the Quality Assurance department
• Risk assessing new clients, projects, audits and vendors.
• SOP creation, development implementation and training
• Gap analysis
• Hosting client audits and regulatory inspections
• CAPA Management
• Management and delivery of the global audit program
• Line manager to 5 auditors
• CAPA metric development
• Awareness of current PV and GCP regulations
• Driving due diligence activities for all vendors/sub-contractors used
• Acting as Client Liaison and main point of contact for any quality related issues
• Reviewing and approving deviations and assessing impact to the global PV system
• Leading the quality assurance department as being a department of excellence and a 'go to' place for all quality related issues.
• Commercialization of the Quality Assurance department
• Risk assessing new clients, projects, audits and vendors.
Training, Audit, Management, Due Diligence, Hosting, Quality Assurance, Implementation, Development, Regulatory, Audit, UP, Manager, Go
2015 - 2016
temp
Quality Assurance Manager
Human Immunology Laboratory.
• Setting up and establishing robust quality management systems
• SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards retaining accreditation
• Escalating GCP and GCLP Compliance Issues.
• Promoting Quality Culture Awareness within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems and vendor audits.
• Driving CAPA to completion for both internally identified GCP/GCLP non-compliance as well as non-compliance identified in audit.
• Generating metrics from reported deviation, CAPA to assist in process improvements
• SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards retaining accreditation
• Escalating GCP and GCLP Compliance Issues.
• Promoting Quality Culture Awareness within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems and vendor audits.
• Driving CAPA to completion for both internally identified GCP/GCLP non-compliance as well as non-compliance identified in audit.
• Generating metrics from reported deviation, CAPA to assist in process improvements
Writing, Audit, Management, Compliance, Quality Management, Hosting, Quality Assurance, Implementation, Development, Audit, UP, Manager
2014 - 2015
temp
Quality Manager (contract)
St Stephens AIDS Trust.
• Providing advice on setting up and establishing robust quality management systems
• Providing consultation advice on SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards attaining regulatory accreditation
• Escalating GCP Compliance Issues.
• Responsible for promoting Quality within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems audits, vendor audits and clinical study audits.
• Establishing working groups to begin planning for the phase 1 accreditation
• Liaising with sponsors/clients with respect to providing appropriate responses to audit findings and ensuring all responses provided are followed up to completion.
• Driving CAPA to completion for both internally identified GCP non-compliance as well AS non-compliance identified in audit.
• Reporting serious breaches to the MHRA and leading CAPA to completion.
• Member of the Management Team and escalated all ongoing issues to the team on a weekly basis.
• Providing consultation advice on SOP development, writing and implementation
• Developing SOPs, Work Instructions, Quality Manual
• Driving Gap Analysis
• Developing strategies for working towards attaining regulatory accreditation
• Escalating GCP Compliance Issues.
• Responsible for promoting Quality within the company
• Hosting all client audits and promoting the company Quality Management System
• Responsible for management and delivery of the audit program to include internal systems audits, vendor audits and clinical study audits.
• Establishing working groups to begin planning for the phase 1 accreditation
• Liaising with sponsors/clients with respect to providing appropriate responses to audit findings and ensuring all responses provided are followed up to completion.
• Driving CAPA to completion for both internally identified GCP non-compliance as well AS non-compliance identified in audit.
• Reporting serious breaches to the MHRA and leading CAPA to completion.
• Member of the Management Team and escalated all ongoing issues to the team on a weekly basis.
Writing, Audit, Management, Compliance, Quality Management, Hosting, Implementation, Development, Regulatory, Audit, UP, Manager
2012 - 2014
temp
QA Program Manager (contract)
Takeda Group Research & Development.
UK
• Deputized for the Clinical Quality Assurance ('CQA') Manager
• Developed, managed and executed strategic systems and/or process clinical QA audit programs for Takeda
• Oversaw the planning, conduct and execution of international audits of clinical sites, documents, databases, vendors and internal systems
• Managed audit teams, including outside contractor auditors
• Identified potential systemic compliance risks, through audit activities
• Provided GCP compliance support
• Acted as lead auditor for all audits conducted which were not sub-contracted to contractors
• Deputized for the Clinical Quality Assurance ('CQA') Manager
• Developed, managed and executed strategic systems and/or process clinical QA audit programs for Takeda
• Oversaw the planning, conduct and execution of international audits of clinical sites, documents, databases, vendors and internal systems
• Managed audit teams, including outside contractor auditors
• Identified potential systemic compliance risks, through audit activities
• Provided GCP compliance support
• Acted as lead auditor for all audits conducted which were not sub-contracted to contractors
Audit, QA, Compliance, Support, Quality Assurance, International, Audit, Manager
2011 - 2012
job
Senior CQA Auditor (permanent)
Chiltern International.
UK
• Deputized for the QA Manager (Europe) as appropriate
• Represented the QA group within the company
• Provided quality support and contributed to process improvement within QA and other departments
• Created (or supervised and/or coordinated the creation of) SOPs required for the proper functioning of the clinical trial process
• Managed European audit program and European auditor's calendars
• Acted as lead auditor for all audits conducted including training auditors
• Attended BARQA Auditing Computerized Systems
• Acted as lead auditor for Computer Systems Validation (CSV) audits
• Deputized for the QA Manager (Europe) as appropriate
• Represented the QA group within the company
• Provided quality support and contributed to process improvement within QA and other departments
• Created (or supervised and/or coordinated the creation of) SOPs required for the proper functioning of the clinical trial process
• Managed European audit program and European auditor's calendars
• Acted as lead auditor for all audits conducted including training auditors
• Attended BARQA Auditing Computerized Systems
• Acted as lead auditor for Computer Systems Validation (CSV) audits
Training, Audit, QA, Support, Audit, Manager
2010 - 2011
temp
GxP Compliance Manager
Spie Matthew Hall.
UK
• Introduced and managed continuous process improvements
• Developed and implemented a system for Change Control, CAPAs and Quality Incidents
• Ensured accurate individual training profiles ('ITPs') for all staff and Good Manufacturing ('GMP') contractors, including pre-qualification and competence
• Developed and managed a training database/system for compliance with ITPs
• Responsible for GxP administration team
• Developed internal and external audit programmes
• Developed archiving system
• Ensured 100% compliance to meet all administration standards set by Spie Matthew Hall, clients and other governing bodies
• Provided GxP/QA consultancy on behalf of Spie Matthew Hall to clients and major stakeholders
• Assured compliance with Medicines and Healthcare products Regulatory Agency ('MHRA') guidance for pharmaceuticals and manufacturers
• Executed internal and external audits to cover systems and vendors
• Presented compliance requirements during team meetings
• Developed a system of document control for SOPs, including periodic reviews
• Wrote and revised SOPs
• Coordinated SOP writing and revisions with other departments
• Developed and implemented security vetting procedures for contractor's access onto site
• Worked to ISO 9001:2008 standards
• Introduced and managed continuous process improvements
• Developed and implemented a system for Change Control, CAPAs and Quality Incidents
• Ensured accurate individual training profiles ('ITPs') for all staff and Good Manufacturing ('GMP') contractors, including pre-qualification and competence
• Developed and managed a training database/system for compliance with ITPs
• Responsible for GxP administration team
• Developed internal and external audit programmes
• Developed archiving system
• Ensured 100% compliance to meet all administration standards set by Spie Matthew Hall, clients and other governing bodies
• Provided GxP/QA consultancy on behalf of Spie Matthew Hall to clients and major stakeholders
• Assured compliance with Medicines and Healthcare products Regulatory Agency ('MHRA') guidance for pharmaceuticals and manufacturers
• Executed internal and external audits to cover systems and vendors
• Presented compliance requirements during team meetings
• Developed a system of document control for SOPs, including periodic reviews
• Wrote and revised SOPs
• Coordinated SOP writing and revisions with other departments
• Developed and implemented security vetting procedures for contractor's access onto site
• Worked to ISO 9001:2008 standards
Administration, Writing, Training, Database, Audit, QA, Compliance, Security, Gmp, Regulatory, Audit, Manager
2007 - 2009
job
CQA Auditor (permanent)
Pharm-Olam International UK.
UK
2007 - 2007
temp
CQA Auditor
GW Pharmaceuticals.
UK
2002 - 2006
job
Clinical Trials Administrator QA
Cancer Research UK.
QA, Administrator
My education
?
-
2002
University of North London
BSc, Microbiology
BSc, Microbiology
Mariem's reviews
Mariem has not received any reviews on Worksome.
Contact Mariem Sarghini
Worksome removes the expensive intermediaries and gives you direct contact with relevant talent.
Create a login and get the opportunity to write to Mariem directly in Worksome.
are ready to help you
and get specific bids from skilled talent in Denmark