Summary
Overview
Work History
Education
Skills
Timeline
Generic

Bernadine Houessou

Summary

Quality Specialist with 15 years’ experience in life science Industry seeking challenge/ contribute towards company Vision/ targets and working towards Class A. My background encompasses a wealth of conducting internal audits of the ISO Management systems.

Overview

20
20
years of professional experience

Work History

Quality Specialist

GMP Healthcare
04.2024 - Current
  • Reviewing and signing off Suppliers Questionnaire
  • Writing up Quality Agreement for various suppliers
  • Supporting with SLA for suppliers
  • Ensure that Policies, Standard Operating Procedures (SOPs) and Internal Operating
  • Supporting with MHRA audit as a back lead Auditor
  • Tracking of incidents within the trials, advising on CAPAs to be implemented
  • Plan, conduct and follow up of audits of high-risk suppliers performed at the suppliers on site premises
  • Follow up and close out all assigned audits including agreement of appropriateness of corrective actions to audit findings
  • Ensure completion in a timely manner
  • Supporting with Quality risk management
  • Recommendations for improvement where appropriate
  • Determine staff SOP training requirements relating to QA and QC in view of their role
  • Write, review and approve risk assessments for new trials

Interim QA Manager

Lloyd pharmacy
06.2023 - 11.2023
  • Company Overview: Clinical home
  • Support with Audit preparation -Writing up , and AUDIT REPORT
  • Leading the GAP Remediation to unsure all our process are complete in timely manner and any implementation action in place
  • Active involvement in the management of the Dot Compliance eQMS covering Deviation/CAPA, Change Control and Audit
  • Expansion of the capabilities of the system to cover other QMS elements
  • Responsible and ensuring we are maintaining the 8 Principle of GMP and ALCOA principle
  • Responsible for reviewing all the batch based on investigation finding for CAPA closure
  • Conducting GMP Refresher Training, and QA induction
  • Overseeing support Quality Management within GCO function
  • Train all employees to the QMS, and assess skills, knowledge and QMS application
  • Clinical home

Compliance Specialist Consultant

Rosemont Pharma
06.2022 - 03.2023
  • Process- Validation Responsible for maintaining process validation can consistently produce a product that meets the required specification
  • Cleaning validation Involves in designing and developing cleaning procedure for new product and manufacturing equipment
  • Developing and implement the processes and systems necessary to ensure the business will meet both the current and legislation pn QMS
  • Ensure consistent quality and standards are upheld by providing cross functional support to ensure GMP compliance
  • To perform impact assessment for all investigations and to establish plans for continual improvement of the QMS in compliance with 2001/83/EC and HMR 2012 1916
  • Continuously ensure the site is in compliance with Eudralex, Volume 4
  • Perform GMP training Consolidate GMP training system under quality assurance
  • Maintain, monitor and improve quality/regulatory culture on site
  • Manage, train and mentor GMP staff within the Company for quality system related aspects
  • Compilation presentation of quality metrics

Equipment Validation Manager

Fujifilm Diosynth Biotechnology
06.2022 - 10.2022
  • Collaborate with cross-functional teams to ensure project objectives are met
  • Perform QA review and approval of validation lifecycle documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) protocols and reports, on incubators, freezers, fridge
  • Perform Data Integrity risk assessment
  • Assist in the monitoring and periodic revalidation and requalification of freezer from one location to another
  • Review and approve validation deviations
  • Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified, and all documentation completed before they are released for GMP use
  • Perform QA review and approval on a range of technical documents including Standard Operating Procedures (Sops ‘and Technical Protocols and Reports
  • Approve risk assessments relating to validation activities
  • Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner

QA Consultant

Guys Hospital
08.2021 - 06.2022
  • Equipment Qualification on HPLC Agilent 1 2 , 3, 4 ,TOC, UV , Centrifuge , weight Balance
  • Perform QA review and approval of validation lifecycle documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) protocols and reports
  • Writing a Procedure for URS with complaint with Annexes 11
  • Supporting on process validation, equipment validation, cleaning validation (swab testing)
  • Writing up a report on Equipment Loads in the SAL3 and 5 Autoclaves using Biological indicators on Thermometric Re-qualification
  • Reviewing Validation Summary Report-Rating requirements-section demonstrated
  • Perform Data Integrity risk assessment
  • Responsible and maintaining Quality risk management

QA Supplier Lead consultant

argenx
02.2021 - 05.2021
  • Supporting the R&D Department
  • Support with Pre inspection documentation
  • Maintaining the GCP metrics
  • Chair Leading GMP/ GCP Stakeholder meetings
  • Leading the continuous improvement and inclusive behavior
  • Write up and reviewing Vendor Quality Agreement and Vendor Qualification report
  • Managing and Reviewing Management tracking system
  • Working closely with collaborators
  • Maintaining and write up GLP and GcLP vendor qualification report
  • Maintaining the Biobank for HBM supplier
  • Report Quality Issues to Production Management Personnel
  • Maintain Quality Assurance Records
  • Establish and enact quality assurance procedures and methodologies throughout the manufacturing and development processes
  • Assess current production and inspection systems and develop new solutions to enhance quality control, frequently working with production managers and other leaders to enact and improve these procedures

Product Quality Review Specialist

Medreich LTD
11.2021 - 02.2021
  • Review of Marketing authorization variation submitted
  • Review of all significant deviations or non-conformance
  • Review of Technical agreement
  • Reporting any abnormal trend of key quality indicators
  • Maintain all process is recorded and actions are proposed for improvement
  • Supporting the QMS to Review change control, OOS, Review all stability and adverse trend
  • Review of significant deviations/investigation and effectiveness of CAPA
  • Review of marketing authorization variation

Compliance Audit Specialists

EMCOR/ GSK
04.2020 - 08.2020
  • Supporting Management review, audits and performance
  • Maintaining documents and records control on QMS
  • Ensure records are legible, readily identifiable, and retrievable
  • Coordinate with Manager to determine audit scope and timelines
  • Conducting MM Audit
  • Management Monitoring Action
  • Third party vendors
  • Quality Agreements
  • Qualification of NON-GXP Vendor
  • Plan and perform audits such as operational, financial and compliance audits
  • Review audit findings and develop action plans
  • Participate in audit meetings and coordinate internal and external audit activities
  • Develop corporate policies and procedures
  • Develop risk models to access and mitigate potential risks
  • Maintain audit documentations according to established standards
  • Organize audit trainings for team for skill development
  • Develop standard tools and procedures to improve audit efficiency

A Specialist

Catapult Cell and gene therapy
11.2020 - 03.2020
  • Maintain the Company QMS in line with good practice (GCP) and good manufacturing practice GMP
  • Reviewing QC batch file
  • Validation protocol on SAL5 Autoclaves using Biological indicators
  • Provide advice on the improvement of GCP and GMP complaint clinical trial systems
  • Manage/create/review SOP
  • Coordinate audits and inspection visit
  • Proofreading all our electronics copy data base
  • Correcting any error from production till final step
  • Generating the management review
  • Updating CAPA.NC.CC Tracker
  • Raising deviation
  • Generate report on KPI metrics
  • Working closely and supporting collaborators

Interim Quality Consultant

MeiraGTX
01.2019 - 08.2019
  • Company Overview: Gene therapy
  • Hosting inspection readiness meeting
  • Review and approval of documentation tracker for SOP, Change control, QMS
  • Develop procedure and techniques for monitoring and measuring QMS processes
  • Implement corrective actions for process failures
  • Support implementation and management on CAPA non-conformity
  • Work closely with QC Manager to maintain compliance and quality of documentation are met
  • Helping on Various QC Testing on Osmolality.vg titre, infectious titre, AAV2, pH appearance, Transgene ID
  • Assist with internal Auditing with QP and summarise my finding
  • Create Sample test plans for validation projects
  • Conducting stability reports/stability protocol based on results generated accordance with product specification
  • Reviewing and approving SOP using Master control software
  • Maintain own workload whilst also assisting senior Scientists in the laboratory
  • Identify correct specifications Using PFS specification for sampling plan
  • And methods for testing, including stability and validation protocols to regulatory standards and guidance
  • Gene therapy

Microbiologist/Quality control Specialists

M S D Merck
12.2006 - 07.2018
  • Responsible for providing microbiology, and exploratory assay support for preclinical vaccine
  • Carrying out Husbandry collection of eggs from supplier
  • Incubate the egg, then transfer to hatch, then the egg becomes small Chick, transfer the chicken to brooding room, feeding, watering pot, chicken
  • Changing and collection of faecal sample and homogenised
  • Collection and processing sample/Dosing/ euthanasia after collection as been made for PVO or for percentage protection (%)
  • Testing various QC activities to ensure quality are met and to detect any defect of the product
  • Interpret and summarize experimental data
  • Bioburden Testing, Water purification, TVCs, Settle plate Active air plates SAB R2A Plates
  • Reading plates, confirmation of Media growth/promotion
  • Review/trending and creating a batch file.EM report using micro data log sheet
  • Conducting Cleanroom Validation
  • Carried out in house Sterility / fertility test on Antigens
  • Using a membrane filtration or direct inoculation
  • Wet chemistry -to analyse our chemical component
  • Conducting a VITEK 2 Compact for microbial identification, gram staining method
  • Gown qualification/Clean Room Procedure and report results to GMP standards

QC Technician

Scipack Research Centre
04.2006 - 08.2006
  • Analysis on Protein Purification, normal human plasma /serum Depleted serum
  • Recombinant protein Patients sample, Disease state plasma and Antibody purification using different test standard
  • With good aseptic technique such as SDS PAGE.ELISA product packed and send out to consumer with Approved FDA regulation
  • We deliver the precise dose through tube every time to Improve our output and minimised wastage

Quality/stability Control

Sanofi Aventis
10.2005 - 02.2006
  • Performing Chemical testing /Dosage form on aerosols and processing inhalation product Metered Dose Inhalers (MDI’s) and nasal sprays on liquid dosage forms
  • Using approved Method Such as HPLC/Wet chemistry
  • With FDA requirements 21 CFR Part 820, 210 and 211 to assure that the potency; purity, safety and stability of our products follow approved specifications
  • Effective manner in compliance with GMP regulatory requirements

Sample Preparation

Syngenta International Research Centre
08.2004 - 09.2005
  • As part of a team prepare a wide range of crop and soil sample ready for residue analysis to GLP principles
  • Record all sample processing labelling, packaging, weighting and movement of sample on a database

Education

B.Sc. (Hons) - Pharmaceutical Science

University of Greenwich
06.2004

GNVQ Advance - Science Level 3

Southwark College
06.2000

GNVQ intermediate - Science

Lewisham College/Putney College
06.1998

GCSEs - Science (C), IT (C), Maths (B), English (C), Design & Technology (C), French

Chestnut Grove school
06.1996

Skills

  • Preparation Approval and Issuing of Documents in MIDAS
  • Management Procedure using Reliance
  • Event and Deviation Management/ Track wise
  • Data integrity/ Fire Extinguisher Use
  • Ultimate development CRA /yellow belt Certification
  • Home office license For GLP animal (Scientific procedures) act
  • QMS 9001:2015 Quality Manual

Timeline

Quality Specialist

GMP Healthcare
04.2024 - Current

Interim QA Manager

Lloyd pharmacy
06.2023 - 11.2023

Compliance Specialist Consultant

Rosemont Pharma
06.2022 - 03.2023

Equipment Validation Manager

Fujifilm Diosynth Biotechnology
06.2022 - 10.2022

Product Quality Review Specialist

Medreich LTD
11.2021 - 02.2021

QA Consultant

Guys Hospital
08.2021 - 06.2022

QA Supplier Lead consultant

argenx
02.2021 - 05.2021

A Specialist

Catapult Cell and gene therapy
11.2020 - 03.2020

Compliance Audit Specialists

EMCOR/ GSK
04.2020 - 08.2020

Interim Quality Consultant

MeiraGTX
01.2019 - 08.2019

Microbiologist/Quality control Specialists

M S D Merck
12.2006 - 07.2018

QC Technician

Scipack Research Centre
04.2006 - 08.2006

Quality/stability Control

Sanofi Aventis
10.2005 - 02.2006

Sample Preparation

Syngenta International Research Centre
08.2004 - 09.2005

B.Sc. (Hons) - Pharmaceutical Science

University of Greenwich

GNVQ Advance - Science Level 3

Southwark College

GNVQ intermediate - Science

Lewisham College/Putney College

GCSEs - Science (C), IT (C), Maths (B), English (C), Design & Technology (C), French

Chestnut Grove school

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Bernadine Houessou