Curriculum Carmen Rodríguez Álvarez

Profile

Experienced pharmacist (16 years +) with vast experience in the Pharmaceutical Industry as Quality Supply Chain Manager and registered EU Qualified Person for IMPs and licensed products (6 years +).

Areas of expertise and interest include clinical research, commercial and clinical supply project management, Quality Management Systems design and optimization, quality metrics / KPI design, technical agreements development, clinical and commercial batch review and disposition, internal and external auditing, regulatory Inspections.

My experience includes working in multicultural and dinamic pharmaceutical organizations across several EU and non EU countries, Belgium, Denmark, The Netherlands, Switzerland, United Kingdom, United States.

Main Achievements

As Quality Lead I have contributed:
• to the success of several blockbuster medicines by providing timely, accurate QP input and batch evaluation, to product from early development to commercialization; by designing, implementing and making improvements to quality processes and by communicating regularly and efficiently with operational teams ( business development, business partners, clinical, regulatory, manufacturing and planning)

• to the licensing of Clinical Labeling, Packaging and Warehouse GMP and GDP Facilities by providing timely and accurate quality input to the project; by performing gap analysis, risk mitigation, defining project milestones and executing project activities as part of the project team.

• to the design, implementation and optimization of Quality Systems, Senior Management Review, Product Quality Review, Control Charts, Quality metrics and reports, batch release and QP certification, product manufacturing and Analytical processes.

• to the local implementation of Global Standards and electronic systems projects (eg: clinical Oracle, SAP for Distribution, LIMS, eDocS, e-archive, TrackW ise, ISOTrain, eClinical Trial Master File, Insight Manager,…).

• to the design and implementation of GMP Training Programs and courses. (OTJ, SOP, Train the Trainer, interactive and Start Up Training).

• to the successful harmonization of internal QP processes (clinical / commercial) by conducting internal QP Forum. The efficiency, compliance and alignment of the processes increased leading to an overall higher customer satisfaction.
Key Skills
Responsible, decisive and collaborative Qualified professional.
Able to assess and manage quality demanding situations quickly and accurately.

Excellelnt knowledge of Nationals and European Law related to the manufacture of medicines and ICH GCP Guidelines.

Able to communicate efficiently accross culture, function and company differences, to develop and manage outside partnerships.
Experienced coach and mentor.

Advanced skills in MS Office package, Project Management (MS Project) and electronic Quality IT systems.
Languages

Spanish (Mother Tongue), English (Professional Profficiency), Dutch (Intermediate level), Danish (Basic level), German (able to read).
Education

Postgraduate Certificate in Clinical Pharmacy, Cardiff University, Shool of Pharmacy, Cardiff, UK (1999 – 2001)
Master Science Degree in Pharmacy, University of Seville, School of Pharmacy, Seville, Spain (1989 – 1995).
Professional Experience

QUALITY SYSTEMS PROJECT MANAGER FREELANCE (2012 – PRESENT)

Formed a co-owned company “Kamara y Rodriguez SL” to provide advice on the creation, optimization and implementation of Quality Management Systems and Quality Assurance services to the Pharmaceutical Industry. Project to date:

UCB – BRAINE L’ALLEUD – BELGIUM (MAY 2016 – PRESENT):

QA Project Manager Expert: Responsible for management and execution of Quality project related to the design and implementation of batch release processes: batch record review and assessment, QP certification and release to market within a commercial pharma organization.
UCB – BRAINE L’ALLEUD – BELGIUM (SEP 2014 – JUN 2015):

Specialist Quality Product Project Support in relation to commercial product lifecycle manufactured by external vendors:

• Product Quality Reviews (system design and implementation).
• Manufacturing process review and process improvement.
• Process and method transfers between manufacturing sites and analytical laboratories.
• Regulatory submissions.
• Validation Protocols and Qualification reports.
• Product Launches.
• Quality Processes.
• Mapping of Quality related product and manufacturing supply chain.
• Commercial Product Cockpit.

JANSSEN PHARMACEUTICAL– LA LOUIVIERE – BELGIUM (2013-2014):

(Interim) Sr Quality Manger: 6 to 8 direct reports.
Quality support on implementation of warehouse management electronic system SAP and Fine Distribution Services.
Quality System optimization: Product Complaint, Returns, Change Control.
KPIs design, control and monitoring. Site Management Review Lead.
Daily QA support to the site operations.
Complaints / Events and CAPAs handling and monitoring.

STAFF ASSOCIATE,QUALITY SYSTEMS, BIOGEN IDEC APS, HILLEROED, DENMARK (2010 – 2011)
Project Manager for Clinical QMS projects: Optimization of clinical supply chain; Projects such as Licensing of a Clinical Label / Pack and warehouse in-house facilities, Process for the transfer of IMP at the Clinical Site IMP, IMP reprocessing procedures, Clinical electronic release, Investigator Initiated Trials, Technical Agreements Process, QP Declaration Procedures, Clinical Technical Product Complaints Process, Comparators Specifications.
QP batch release and certification of IMPs.
Quality Review and assessment of IMPDs and Trial Master File documentation. Managing and conducting biweekly QP Forum.
Local implementation of clinical and regulatory electronic systems.

SENIOR MANAGER QUALITY ASSURANCE, BIOGEN IDEC APS, HILLEROED, DENMARK (2007 – 2010)
4 to 6 direct reports.
QP batch release and certification of clinical and commercial medicinal products. Optimisation of Quality Systems related to the disposition of clinical products (eg
Newly commercialized products processes, release certificates improvements, Establishment of Technical Agreements with Sponsor, clinical label and clinical recall processes)

Provision of QP input to cross functional teams eg: support to clinical and licensed products development, Regulatory Inspections, external and internal auditing, investigations and complaints.
Designing Quality Performance Metrics and Quality Reports to contribute to
Professional Experience

Departmental Continuous Process Improvement and Operational Excellence. Responsible for training and mentoring of newly recruited QPs.
Quality Review and assessment of product registration documentation. Contribute to the local implementation of clinical disposition electronic systems (clinical TrackWise and OPM).

MANAGER QUALITY ASSURANCE, BIOGEN IDEC BV, HOOFDDORP, THE NETHERLANDS (2004 – 2007)
2 directs reports.
Responsible for QP batch release and certification of clinical and commercial medicinal products.
Responsible for the design, implementation and maintenance of clinical disposition processes to fulfill EU requirements of the Clinical Trial Directive.

Providing Quality input to Product Quality Managers and CMO for product development initiatives.
Responsible for developing training material and training qualification for newly recruited QPs and department personnel.
Restructuring of QMS due to the company relocation activities.
SUPERVISOR QA DOCUMENTATION SYSTEMS, BIOGEN IDEC BV, HOOFDDORP, THE NETHERLANDS (2003 – 2004))
4 to 6 direct reports.

Optimization of the QA Documentation and Change Control Procedures for International Quality Department and Affiliates.
Optimization of the QA Documentation data collection and reporting processes to increase customer satisfaction.
Designing systems for the management of QA Archive.
Responsible for the implementation at a local level of Quality Global Standars and electronic documentation management systems (eDocS).
Creating Training requirements for QA Documentation personnel. Support Product Development initiative and relocation activiities.
SPECIALIST QA TRAINING SPECIALIST, BIOGEN BV, HOOFDDORP, THE NETHERLANDS (2002 – 2003)
Responsible for the implementation at a local level of Training Harmonisation Standards and global electronic training management systems (IsoTrain).
Develop and implement at a department and individual level a set of training requirements and programas related to GMP Training, Quality Sytems Training Modules, Train the Trainer Qualifying modules.
Facilitate Training implementation at Affiiliate Offices.

ONCOLOGY / ROTATIONAL CLINICAL PHARMACIST, HEATHERW OOD AND WEXHAM PARK HOSPITALS NHS, ASCOT/ SLOUGH, UK (1999 – 2001)
Responsible for the day to day management of the aseptic chemotherapy unit. Provision of pharmaceutical care in a wide range of clinical specialities such as
paediatrics, general medicine, surgery, geriatrics.
Provision of Medicine Information Services to the public and healthcare professionals.

PHARMACEUTICAL TECHNICIAN TEMP SPECIALS UNIT, MARTINDALE PHARMACEUTICALS LTD, ROMFORD, UK (1998 – 1999)
Batch and extemporaneous manufacturing of Special medicines. Medicine Information Services to customers.

COMMUNITY PHARMACIST, SAUCEDO AND VALDES PHARMACY, SEVILLE, SPAIN (1996 – 1997)

Professional Development Courses

2015 QP Forum : European QP Association. Berlin. Germany(*).
2013 QP Forum: European QP Association. Lisbon. Portugal.
2012 Quality Consultancy II: Quality Certification, Confederacion de
Empresarios de Andalucía, Sevilla, Spain.
2011 Process Development of Oral Solid Dosage Forms and Application
of QbD, PharmaTraining, Hilleroed, Denmark.
2010 Improved Problem Solving & Decision Making, Management Centre
Europe, Hilleroed, Denmark.
2010 GMP Rules, Pharmakon, HillerØd, Denmark.
2010 Project Management Advanced, Third Vector Training, Hilleroed,
Denmark.
2009 4th Qualified Person FORUM 2009, QP Asssociation, Barcelona,
Spain.
2006 Training Course on Quality Management in Pharma and Biotech,
Delft University of Technology.
2006 Practical Formulation, Manufacturing and Analysis, David Begg

2005 associates, University of Strathclyde, UK.
GMP for Cllinical Trials Manufacture and Supply. David Begg
associates, UK.
2005 MS Words: Word Forms and Templates, CompuTrain, The
Netherlands.
2005 Advanced Dutch Language, Linguarama, The Netherlands.
2004 Basic Management Skills, Third Vector Training, The Netherlands.
2003 Problem Solving Quality Tools, American Society for Quality.
2003 MS Project 2000 Basis, CompuTrain, The Netherlands.
2003 Coaching Skills, Global Leadership Development. France.
2003 Basic Dutch Language II, ROC van Amsterdam, The Netherlands.
2003 Coaching Skills, Boertien en Partners, The Netherlands.
2002 General GMP, David Begg associates, The Netherlands.
2002 Elmentary Course for Cliniical Research Associate, Sticares /
InterACT, The Netherlands.
2001 Aseptic Preparation and Dispensing of Medicines Course, University
of Leeds, UK.
2000 Clinical Continuing Education Courses, The College of Pharmacy
Practice, Oxford, UK.
1999 Pharmaceutical care and Drug Interaction workshops, Centre for
Pharmacy Postgraduate Education, Manchester, UK.
1997 English Language Diploma, Westminster Adult Service College,
London, UK.
1996 Water Analysis and chemical treatment technical course. Fundacion
Esculapios, Seville, Spain.

(*) Prospective enrolment. Course date November 2015
Professional Membership

Royal Pharmaceutical Society (former RPSGB) UK: Reg nr E492. BIG Register Apotherker, The Netherlands, Reg nr 09057021217. European QP Association. European Compliance Academy.

Professional Development Courses
2015 QP Forum : European QP Association. Berlin. Germany(*).
2013 QP Forum: European QP Association. Lisbon. Portugal.
2012 Quality Consultancy II: Quality Certification, Confederacion de
Empresarios de Andalucía, Sevilla, Spain.
2011 Process Development of Oral Solid Dosage Forms and Application
of QbD, PharmaTraining, Hilleroed, Denmark.
2010 Improved Problem Solving & Decision Making, Management Centre
Europe, Hilleroed, Denmark.
2010 GMP Rules, Pharmakon, HillerØd, Denmark.
2010 Project Management Advanced, Third Vector Training, Hilleroed,
Denmark.
2009 4th Qualified Person FORUM 2009, QP Asssociation, Barcelona,
Spain.
2006 Training Course on Quality Management in Pharma and Biotech,
Delft University of Technology.
2006 Practical Formulation, Manufacturing and Analysis, David Begg

2005 associates, University of Strathclyde, UK.
GMP for Cllinical Trials Manufacture and Supply. David Begg
associates, UK.
2005 MS Words: Word Forms and Templates, CompuTrain, The
Netherlands.
2005 Advanced Dutch Language, Linguarama, The Netherlands.
2004 Basic Management Skills, Third Vector Training, The Netherlands.
2003 Problem Solving Quality Tools, American Society for Quality.
2003 MS Project 2000 Basis, CompuTrain, The Netherlands.
2003 Coaching Skills, Global Leadership Development. France.
2003 Basic Dutch Language II, ROC van Amsterdam, The Netherlands.
2003 Coaching Skills, Boertien en Partners, The Netherlands.
2002 General GMP, David Begg associates, The Netherlands.
2002 Elmentary Course for Cliniical Research Associate, Sticares /
InterACT, The Netherlands.
2001 Aseptic Preparation and Dispensing of Medicines Course, University
of Leeds, UK.
2000 Clinical Continuing Education Courses, The College of Pharmacy
Practice, Oxford, UK.
1999 Pharmaceutical care and Drug Interaction workshops, Centre for
Pharmacy Postgraduate Education, Manchester, UK.
1997 English Language Diploma, Westminster Adult Service College,
London, UK.
1996 Water Analysis and chemical treatment technical course. Fundacion
Esculapios, Seville, Spain.

(*) Prospective enrolment. Course date November 2015
Professional Membership

Royal Pharmaceutical Society (former RPSGB) UK: Reg nr E492. BIG Register Apotherker, The Netherlands, Reg nr 09057021217. European QP Association. European Compliance Academy.