Quality Project Manager
Resume:
IGNACE VALLEJO
*** ******* ******, ********, *** York 11224
actfc5@r.postjobfree.com
SUMMARY
With over 15 years of experience in the Biotech/Pharmaceutical industry in Quality Assurance and Quality Control with extensive regulatory requirement knowledge
Conducted Product Investigations
Inspection of all product packaging to determine a non-negative product impact
Conducted both internal and external audits
Hosting FDA Inspections
Conducted monthly GCP/GMP training for all new Employees regardless of position
Delivered 100%, on time and before due date all reviews and releases of batch records
Initiated changes to S.O.P.'s to ensure compliance with all GCP’s and GMP’s
10 years of experience conducting GCP audits, CROs & Vendors audits
Multiple European audits including France & Russia
AREAS OF EXPERTISE
Fluent in Spanish, French, Italian and Portuguese
Knowledge of GCP, cGMP, GLP, GXP requirements
Certified Risk Management and Six Sigma "Black Belt"
Certified Quality Auditor GMP
Internal and external Audits
International audit experience: UK. France, Spain, Italy, Japan and Germany
National Audits: MA, CT, NJ, California, etc.
Release of Raw Material.
Batch reviews and release
Medical/Scientific Writing
QA/QC
TrackWise and LIMS system
Risk assessment, root cause, exception reports, CAPAs, deviation reports, investigation analysis and non-conformance
21 CFR part 211 guidelines
EXPERIENCE
Virbac USA, Saint Louis, MO. 04/2014 -12/2015
Belcan Technical Services,
Deviation Writer Consultant
Investigated deviations from QC department, this included assessing the product impact, determining the root cause and implementing appropriate CAPA utilizing deviation data- base (GMPs).
Ensured all assigned deviation investigations are compliant with internal procedure and FDA regulations.
Audited and monitored the compliance status of company quality related operations and subcontractors. Maintained audit schedules and quality audit files for regulatory agencies.
Reviewed and approved internal and external manufacturing records, batch records,
protocols, and analytical records. Monitored and reviewed and /or approved CAPAs, Deviations, amendments, investigations, out of specifications results and
nonconformance.
Glatt Air Pharmaceutical Services, Ramsey, NJ 02/2014 - 04/2014
Senior Compliance Specialist Consultant
Executed manufacturing investigations within the company for all products both liquid and solid.
Reviewed and approved internal audits of the facility.
Closed CAPAs and deviations before due date.
Planned International audits for the year in India and Germany.
Investigated and wrote investigations.
Performed internal/external audits, and trend investigations.
Reviewed SOPs, and protocols from various departments and clients.
Maintained training records, and updated spreadsheets for investigations, CAPAs, monthly metrics, and GMP training.
Novartis, Suffern, NY 06/2012 - 07/2013
Consultant QSC Deviation Investigator
Proposed, planed and established systems and procedures to ensure product quality and compliance with cGMPs.
Identified root causes of problems, provided recommendations and assured timely implementation of appropriate corrective actions.
Formulated solutions to the exception reports through meetings and 3rd party teleconferences leading to product release.
Ensured all assigned deviation investigations are compliant with internal procedure and FDA regulations.
Identified true root cause of the incident.
Increased the effectiveness of the investigation, resulting in a lasting solution.
Lonza Biologics, Portsmouth, NH 03/2012 - 06/2012
Consultant Deviation Writer
Investigated deviations from all departments, including assessment of product impact, determining the root cause and implementing appropriate CAPA utilizing TrackWise
deviation database. (GMPs).
Ensured all assigned deviation investigations were compliant with internal procedures and FDA regulations.
Proposed solutions to the exception reports through meetings, 3rd party teleconferencing and investigations.
Delivered investigations and exception reports on time by executing each investigation, as follows:
Description, Purpose of the step, Investigation Summary, Root Cause, Impact product Quality, and Justification for no CAPA.
Audited and monitored the compliance status of company quality related operations and subcontractors.
Maintained audit schedules and quality audit files for regulatory agencies.
Reviewed and approved internal and external manufacturing records, batch records, protocols, and analytical records.
Monitored and reviewed and /or approved CAPAs, deviations, amendments, investigations, out of specifications results and nonconformance.
BARC USA, Inc., Lake Success, NY 03/2011 - 06/2011
Quality Assurance Manager GCP Consultant
Executed clinical studies for multiple Global Pharmaceutical Companies in accordance with the protocols, SOPs, ICH-GCP and other regulations and guidelines.
Created scripts for GCP and provided regular clinical status information to team members (Project Managers, and CRA).
Served as the Single Point of Contact for selected CMOs, Pharma/Biotech,
Pharmaceuticals and CRO to assess quality and compliance with procedures, quality agreements, Quality Systems Regulations.
Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents.
Provided input to the annual audit plan, schedule and auditors.
Prepared timely, well-written reports and obtained/evaluated audit responses while managing CAPAs.
Managed contract auditors as needed.
Supported Health Authority inspection activities for domestic and international projects.
Supported/provided quality system/GxP training to staff and developed/administered SOPs as well as controlled FORMS.
Maintained other controlled documents related to the QA unit and QA systems/tracking mechanism for QA audits, CAPA, Quality Systems, etc.
Maintained a high degree of knowledge of global industry expectations, GCP regulations and provided GCP expert advice/guidance to staff in support of GxP Operations.
Assured that every test was performed as per protocols (Urine test, blood test, HIV test, Serum, etc.)
Developed SOPs under GCP guidelines and regulations.
Performed Internal & External Audits.
Conducted training on GCP and Good Documentation Practices.
Created and maintained a strong relationship with the leadership team and participated in all appropriate meetings and venues.
Worked with the Clinical and Pharmacovigilance Management and Quality Management team to ensure continuity.
Worked with the Director of Quality Assurance & Auditing to ensure an appropriate strategy and execution for audits through defined processes and practices.
Documented deviations or deficiencies through trend and root cause analysis and worked with the appropriate team and internal QA Staff to implement a CAPA system and processes.
Fostered consistent Quality processes between the various divisions of clinical,
Pre-clinical and manufacturing.
Ensured that all quality based deliverables were complying with regulatory and quality policies and procedures and timelines were met and observations were corrected.
Collaborated with the Directory of Quality Assurance & Auditing, to ensure all the appropriate SOPs were in place and that the appropriate level of training and
comprehensive had occurred.
Worked with project teams on their quality deliverables.
Ensured direct-report staff was appropriately resourced supported and had the tools and direction to properly execute their function.
Hospira, (Abbott Laboratories), McPherson, KS 09/2010 - 02/2011
Consultant QA (CAPA, OOS, Deviation and Investigation Specialist II)
Performed a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, training programs, data and documentation reviews and analysis.
Proposed, planned and established systems and procedures to ensure product quality and compliance with cGMPs.
Provided solutions to the exception reports through meetings and 3rd party teleconferencing which led to the release of products such as Demerol Hydrochloride Injection, Morphine sulfate inj and Vacomycin, Marcaine HCL, Erythromycin Lactobionate, Heparing Sodium Inj, and Erythrocin Lactoblonate, etc.., which products were released to 3rd parties with acceptable results.
Delivered investigations and exception reports on time by executing each investigation, as follows:
Fishbone: Personnel, Methods, Equipment, Material, Historical, Miscellaneous.
Risk Assessment: Scope, Objective, Assumption. Acceptance Criteria, Risk assessment, Results/Recommendation.
Root Cause: Machine, Material, Environment, Personnel, and Method/Design.
Exception Report: Description (Event), Impact Assessment (Final Impact Assessment, Investigation Detail, Time of Events), Historical Check/Investigation Analysis (Historical Review, Investigation Analysis (personnel), Equipment/Instrument Assessment, Material, Process/methods (Process Overview), Investigation Findings (Scope, Root Cause Classification, Root cause description, Correction Type, Recommended Actions, Summary and conclusions.
The results of these investigations produced an exceptional improvement in all processes, which reduced investigations by 86.25%.
Worked closely with immediate supervisor to ascertain criteria that met company values and profitability goals.
Provided guidance and expertise to the Company, contract laboratories and Client companies in matters relating to microbiology, quality control and stability studies.
In order to effectively manage the stream of deviations being worked on:
Well organized
Interacted effectively with personnel (line personnel and management) when conducting interviews.
Reviewed SOPs, validation data, conducted inspections, and audits.
Issued investigation conclusions in a timely manner.
Writeresult division of 3C Company, Inc. Kenilworth, NJ 12/2009 – 04/2010
QA Manager GCP (Consultant)
Executed a variety of studies for multiple Countries/Languages in accordance with the protocols, SOPs, ICH-GCP and other regulations and guidelines.
Created scripts for GCP and provided regular clinical status information to team members.
Developed SOPs under GCP guidelines and regulations.
Trained sites for clinical studies, Russia (Moscow), Japan (Tokyo), Colombia (Bogota), Belgium (Amsterdam), France ( Paris), etc..
Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents
Provided input to the annual audit plan, schedule and auditors
Prepared timely, well-written reports, obtain/evaluate audit responses and manage CAPA
Managed contract auditors as needed
Supported Health Authority inspection activities for domestic and international projects
Supported/provided quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit
Maintained applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc.
Maintained high degree of knowledge of global industry expectations, GCP regulations and provided GCP expert advice/guidance to staff in support of GxP Operations
Performed additional QA responsibilities as directed by QA Director.
Provided support, training, and a basis for the GCP Guideline and Regulation within the organization.
Enhanced protocols, making them more understandable to the clients.
Improved profitability of the entire company team by approximately 42% for QA while reducing the team by 12%.
Grew a staff of job agents from its inception of 4 agents to 30 agents fully trained.
Worked closely with immediate supervisor to ascertain criteria that met company values and profitability goals.
Traveled regionally 50% for Training purposes along the East Coast, to the Midwest and Overseas.
Laureate Pharma, Inc., Princeton, NJ 02/2005 – 03/2009
Sr QA Compliance Specialist GCP and GMP
Performed a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, training programs, data and documentation reviews and analysis.
Proposed, planed and established systems and procedures to ensure product quality and compliance with cGMPs.
Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents
Provided input to the annual audit plan, schedule and auditors
Prepared timely, well-written reports, obtained/evaluated audit responses and manage CAPA
Managed contract auditors as needed
Supported Health Authority inspection activities for domestic and international projects
Supported/provided quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit
Maintained applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc.
Maintained a high degree of knowledge of global industry expectations, GCP regulations and provided GCP expert advice/guidance to staff in support of GxP Operations
Performed additional QA responsibilities as directed by QA Management.
Organizeded a R &D team to determine the effectiveness and safety of an antibody cancer drug for Prostate Cancer.
Audited clinical investigator, TMFs, systems/process, document & vendor audits/assessments.
Project Manager for the installation of the LIMS system creating templates for the QC, Micro, Material control (Raw Material), and F&F Departments.
Managed 4 quality compliance individuals.
Reviewed all audits: SOP systems, data system, QC Department, Micro Dept, USP Dept, Downstream Dept, QA system, Material control, R&D, Metrology System, Validation System, GCP audits, GXP audits, GLP audits and Manufacturing audits.
Evaluated non-conformances and assessed quality impact, recommended corrective actions and followed up to ensure corrective actions implemented were effective.
Provided QA presence in the Facility and Metrology areas by conducting compliance walkthroughs and ensure compliance with FDA and other regulatory agency requirements.
Partnered with Facility and Metrology personnel to resolve compliance issues and ensure a successful compliance profile.
Ensured compliance observations associated with LaureatePharma Facilities were adequately addressed and completed on schedule.
Reviewed standard operating procedures, validation protocols/reports, Work Orders and Job Plans.
Interacted with FDA and other regulatory agencies, as required.
Performed qualitative and quantitative chemical analysis of raw materials.
Coordinated testing responsibilities to ensure QA test support.
Investigated testing abnormalities and implements CAPA.
Validation of protocols, SOPs, Specifications, and test methods for all clients.
Provided guidance and expertise to the Company, contract laboratories and Client companies in matters relating to microbiology, quality control and stability studies.
Coordinated and conducted periodic internal audits as well as audits of contract testing laboratories, vendors, and other contract service providers as needed.
Interfaced with other departments such as Manufacturing, Engineering, R&D, Downstream processing, upstream processing and QC.
Bristol Myers-Squibb, Garden City, NY 01/2001 – 12/2004
Quality Control Scientist
Focused on cross-functional operations to assure that the raw material department operated within cGMP and SOP requirements. Reported any deviation from procedure to appropriate personnel.
Accomplished a 20% reduction of deviations (Q.I.R) by successfully performing research of analytical methodologies to test formulations developed, according to USP, NF and EP.
Strategically selected a panel of scientists to validate new product (600mg Sustiva) for FDA approval.
Resolved non-compliance of SOP by scientists for testing of production product resulting in timely release of product.
Led cross-functional team to confirm notebooks from other scientists to comply with FDA regulations.
Orchid Biosciences (Formerly Lifecodes), Stamford, CT 2000-2001
Clinical Laboratory Analyst GCP
Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents
Provided input to the annual audit plan, schedule and auditors
Prepared timely, well-written reports, obtained/evaluated audit responses and manage CAPA’S
Managed contract auditors as needed
Supported Health Authority inspection activities for domestic and international projects
Supported/provided quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit
Maintained applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc.
Maintained high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations.
Accountable for all commercial activities associated with processing, analysis and reporting of samples for DNA-based HLA typing for organ transplants.
Managed comparative procedure and formulated DNA-micro-array analysis resulting in an increase of 15% of donors' analysis.
Impath, The Cancer Company, New York, NY 1999 - 2000
Consultant, Quality Assurance GCP
Ensured laboratory compliance resulting in reduction of laboratory investigation reports by 30%.
Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents
Provided input to the annual audit plan, schedule and auditors
Prepared timely, well-written reports, obtained/evaluated audit responses and manage CAPA’S
Managed contract auditors as needed
Supported Health Authority inspection activities for domestic and international projects
Supported/provided quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit
Maintained applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc.
Maintained high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations.
Ensured laboratory compliance resulting in reduction of laboratory investigation reports by 30%.
Developed and managed a secure protocol which increased production by $1.5 M annually.
Pfizer, Brooklyn, NY 1993 - 1999
Associate Quality Control Scientist
Initiated documentation of components and recorded all testing upon their completion according to USP and EP, in compliance with FDA.
Established product testing by increasing speed of testing process. (Zyrtec, Diflucan, Zoloft, and Viagra.)
Performed and documented quality control procedures of each production lot.
Organized reference and internal standards for easy access.
Reviewed all volumetric solution log books to assure that all safety requirements were met.
EDUCATION
Adelphi University, Garden City, NY
MS, Biology
University of Rochester, Rochester, NY
BA, Biology
PROFESSIONAL DEVELOPMENT
CFPA
Certified Risk Management and Six Sigma "Black Belt”
CFPA
Certified Quality Auditor GMP
Brooklyn College
Salvatore Linguistic Award
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