Ibraham Kamara

PROFESSIONAL SUMMARY

Highly resourceful trustworthy and “Hands On” Sr. Quality Engineer Consultant with a broad working expe-rience in the pharmaceutical industry (15 years) with several years spent on management of QMS projects within the medical device industry. Working experience in the Netherlands, Denmark, Switzerland, collabo-ration with North American, Swiss and German pharmaceutical facilities.

• Expert working knowledge of the Quality Systems Regulatory Framework and Industry Standards related to Pharmaceutical and Medical Device Industries, GMP and GDP European Directives, ICH Q7 to Q10, FDA cGMP and various ISO standards (ISO 13485; 14971, 9001-2008; 13408, 14644 etc. etc.).

ACHIEVEMENTS AND KEY SKILLS

• Innovative Contractor with Extensive Experience in Compliance and Business Gap analysis of the supply chain and QMS processes. Achievements: Mapping out Supply chain processes, Product Launch map and activity plans, including capacity model, KPIs, Standard operating pro-cedure and Templates.

• Adaptive and collaborative Personality, able to work across cultures, sites and functions. Achievements: Process optimisations across sites including CMOs and 3PLs Global QMS poli-cies with contractors. Improvements of product and process deviations and complaints, eventually making the processes more compliant and cost effective.

• Expert Working Knowledge of Product and Process computer system validation Regulatory Framework. Achievements: QA lead planning and design phases of validation strategy, design and writing of validation test protocols and reports, reviewing and approval of validation test documentations during design phases, IOQ and PQ technology transfer.

• Expert Working Knowledge of the QMS regulatory framework and Industry standards related to the Biopharmaceutical and Medical Device industry including the European directives on GMP, GDP, ICH guidelines (ICH Q7 – Q10), 21 CFR. Part 11, GAMP 5 and ISO standards (ISO 13485; 14971, 9001-2008; 13408, 14644 etc. etc.).

• Excellent Auditing Skills developed over years of auditing QMS systems; provided significant input towards the optimisation of systems through planning, execution and timely reporting of observations.

• Flexible multi task and able to change priorities according to project or organisation needs.

• Strong communication skills in (English, Dutch, Spanish and French) with innate ability to advice and influence multi-disciplinary teams

• General knowledge in data analysis and statistical method

• Pragmatic and dedicated with high capacity to work independently and as part of a team

PROFESIONAL EXPERIENCE

MANAGER AND CO-OWNER KAMARAYRODRIGUEZ CONSULTANTS (2012 – Present)
QUALITY SYSTEMS MANAGER, KAMARA Y RODRIGUEZ S.L

• Managing Quality Projects from design to implementation: Risk Management Tools design, KPI Process design and implementation, Senior Management Review process design, General Pro-cess Maps from Product Registration to Post Release Holds.

UCB BRAINE, BELGIUM (05-2014 – 01/2015)
SENIOR CONSULTANT QA SUPPLY CHAIN PROJECT: POST RELEASE HOLDS, QAA STREAM MAPPING AND STABILITY PROGRAMS.

• Review and approve supplier QAAs
• Review and approve validation documentations for cold chain supply
• Lead Identified QA Projects from risk analysis to the implementation of improvement recommendations.
• Generate collection of data using appropriate QMS tools (FMEA, Pareto Chart, lean etc.) and lead the analysis of the issues identified to determine business, regulatory and compliance impact.
• Create mitigations for the identified risks.
• Lead the optimisation of the launch process at UCB.
• Participate in the implementation and monitoring of the elected tools.
• Review the stability strategy for global products according to local and international regulatory re-quirements.
• Provide QA support (write and review of project reports) for all commercial initiatives and activities at the supported vendors as defined by the Technical Supply Teams.
• Work closely with all stakeholders to identify quality issues at all stages of the product life cycle from initial commercialisation including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), and Products improvements to phase out for an assigned vendors.
• Provide expert QA advice, troubleshooting and hands on for general and technical operational QA activities.

MERCK SHARPE DOME BV, NETHERLANDS (09-2012 – 03/2013)
SENIOR CONSULTANT QA PRODUCT AND STABILITY COMPLIANCE ASEPTIC PRODUCTS

• Manage product transfer between departments and between sites (review and approve process and product validation documentations including API & Fps)
• Managing product stability program (process optimisation, change control and implementation, OOS management).

• Leading and coordination of cross functional root cause investigations teams, Designing deviation mitigations and monitoring improvements of CA- PAs implementation.

• Write cross functional investigation meeting minutes and final investigation report

• Product and process risk assessment, use of fishbone analysis, decision tree analysis, rule in rule out analysis, flow charts, failure mode effect analysis-FMEA, Monte Carlo analysis.

• Stability Process optimisation to align with global systems implementation initiative (gap analysis, mapping processes and procedures, SOPs review, development and implementation, training of personnel).
MERCK SHARPE DOME BV, NETHERLANDS (10/2011 – 08/2012)
SENIOR CONSULTANT QA PHARMA & MEDICAL DEVICE PRODUCT COMPLAINTS COMPLIANCE
• Supply chain Product Complaint Handling (review, assess impact, investigation)
• Product and process risk assessment (fish borne, decision tree analysis, rule in rule out analysis-RIRO, flow charts, failure mode effect analysis-FMEA, Monte Carlo analysis etc.
• Leading and coordination of cross functional root cause investigations teams (QP, Regulatory Af-fairs, Medical Affairs, Stability, and Manufacturing) across different sites and liaise with authorities as required.
• Writing and implementation of departmental Standard Operating Procedures.
• Optimisation of the complaint handling process to align with global procedures.
• Trending of complaint data and provision of monthly reports.

AMGEN BV, NETHERLANDS (01/2011 – 07/2011)
QA CONSULTANT MEDICAL DEVICES
• Product Complaint Handling (review, assess impact, investigation).
• Managing Investigations (Safety, Quality, trends, reports).
• Write cross functional investigation report and present to top Management
• Leading and coordination of cross functional root cause investigations teams (QP, Regulatory Af-fairs, Medical Affairs, Stability, and Manufacturing etc.).
• Writing and implementation of departmental Standard Operating Procedures.
• Oversee of Affiliate offices to aid compliance with requirements.
• Optimisation of the complaint handling process.

NNE PHAR- MAPLAN, DENMARK (12/2007 – 10/2010)
SENIOR QUALITY ENGINEER & VALIDATION CONSULTANT
• Performing Commissioning and Qualification activities for CSVs, equipments, Processes etc.(failure mode risk analysis (DFMEA, PFMEA and CFMEA) for automated equipments, software and processes based on regulatory and project specifications needs.
• Work as subject matter expert in commissioning and validation activities of automated equipments and test methods for different clients. Including Novo Nordisk, Pronova, Biogen-Idec, GSK, Barvaria etc.
• Review and approval of IOQ, PQ/PV Validation protocols (test documents and validation reports for QC laboratories, primary and secondary packaging, warehouses, bioreactor, HVACs, media preparation tanks, CIPs, Trains, utilities cleaning validation etc. example subcontractors welding documentations, flow diagrams, equipment diagrams, equipment manuals and specification, P & ID´s and more).
• Act as responsible for for equipment and software change control oversight
• Performing site walk downs to verify facility layout and equipment installations against P & ID´s (Biogen-Idec, Pronova, Barvaria, GSK…)
• Review and approve validation test documents for computerised systems example.
• Handling and resolution of validation non-conformities.
• Review, approval and implementation of change control activities example equipment calibrations and SOP updates.
• QA Documentation and deviations management for products in development and in the market.
• Coordination of sub-contractors activities on behalf of clients (perform external GMP audits).
• Prepare equipment design review report, validation procedures and validation reports on behalf of clients. Good knowledge in the implementation of Quality by Design-QbD and Process Analytical Technology-PAT and ASTM (E-2500) and six sigma.

GENMAB, NETHERLANDS (02/2005 – 06/2007)
QA SPECIALIST: CMOs FOR ASEPTIC FILLING AND PACKAGING
• Participate in software risk assessment projects
• Review and approve software validation documentations including: validation master plan, IOQ, and PQ validation protocols, test scripts, deviations, changes, IOQ and PQ reports etc.
• Planning and participation in internal and external quality system audits.
• Prepare audit reports and report within time frame
• QA batch documentation review (stability data).
• Preparation of regular trend analysis quality systems data.
• Coordination of QA Exception activities
• Manage product transfer between departments and between sites (review and approve process and product validation documentations including API)
• Review and approve supplier QAAs
• Review and approve validation documentations for cold chain supply
NOTOX, NETHERLANDS (10/2002 – 01/2005)
GLP QA AUDITOR
• GMP/ GLP auditing activities (Planning, participation, report writing, following up to closure on Observations)
• Coordination of QA Validation activities for computerised related systems.

SYNCO BIOPARTNERS, NETHER- LANDS (05/2001 – 09/2002)
PROCESS DEVELOPMENT OPERATOR: FORMULATION, FILLING & FINISHING

• Technical operation during the aseptic development and manufacturing of middle and end product.
• IPC testing monitoring in the fermentation, filling and finishing and purification.
• Responsible for quality data of batch manufacturing records.
• Responsible for investigation and reporting of process deviations
EDUCATION

Master Science, Industrial Drug Development – University of Copenhagen – Denmark (2013).
Bachelor of Science, Biomedical Sciences – University of Westminster – United Kingdom (2001).

PROFESSIONAL DEVELOPMENT COURSES

• Descriptive Statistics and Data Scientist Toolbox (on going).
• 360o Approach towards International Corporate Governance (2013).
• Biopharmaceuticals-Pharmaceuticals Safety Assessment (2012).
• MS Office 2010 (2012)
• Pharmacology (2011).
• QbD/PAT Conference (2010).
• QMS: Auditor / Lead Auditor (2010).
• QMS: Project License (2011).
• Clinical Pharmacology and Biostatistics (2009).
• Non-clinical Safety and Toxicology (2009).
• Drug Formulation and Delivery (2009).
• QA, QC, GXP for Pharmaceutical Production (2009).
• Drug Regulatory Affairs in Drug Development (2008)
• Chemical Process and Production of API (2008).
• Discovery and Development of Medical Device (2008).
• Drug Discovery (2007).
• Stability Testing (2006).
• Risk Management (2006).
• Computer System Validation (2006).
• MS Project (2005).
• Clean Room and E-sterilization (2002)

LANGUAGES

• English (Mother Tongue)
• Dutch (Full professional proficiency)
• Spanish (Advanced)
• French (Intermediate)
• Danish (Beginner)