TECHNICAL SKILLS:

TECHNICAL/ INSTRUMENTATION SKILLS: Strong knowledge of CMC (Module 2 and 3); Validation/ Document Storage/ Process Review/ Technical Writing of Scientific and Sales/ Marketing Material, Analytical Chemistry/ Confidential, HP, Waters, ThermoSeperation, and IBM HPLC systems, Varian and HP GC’s, Immunoassay TDX, Automated & Manual Dissolution Apparatus, Disintegration, UV/Vis, IR, DAD and Wet Chemistry - KF, ID, pH, TLC, etc.

INFORMATION SYSTEMS/ APPLICATIONS: Knowledge of Documentum / advanced techniques -Excel, Adobe Acrobat Professional / use of Compose and ISI Toolbox Menus. Strongly familiar with Regulatory guidelines (ICH guideline, etc), EDMS, Trackwise, Global Product Registration (GPR)/ Register systems, GDMS, Confidential, RCCM, CTRAX, Quantum, View Point and SAP. WinNT-NT Server, 2000 Pro-2000 Server, Client/Server- Network Design, Chemstation, Watson-Nugenesis LIMS, Multi- vendor Confidential Programs, Peakpro, Allin1, Chromlink, Cyberlab

PROFESSIONAL EXPERIENCE:

Confidential

QA CRS/ CMC/ Validation/ Linguist / Systems Analyst

Responsibilities:

• Manages interaction between PCO and GCMC i.e. handlings of queries, comments, and contingencies
• Executes and facilitates updates and approves RANs
• Updates document status information in depositories, RCCM, Confidential, etc.
• Ensures updates of appropriate CMC and change management systems

Confidential

Collation Analyst /QC Analyst

Responsibilities:

• Examined Spanish, English and Portuguese dossiers content and history in systems or copies of files (e.g. PDF or MS Word) retrieved from Country Affiliates.
• Reviewed historical records of initial dossier submissions, change controls, variations and Confidential Correspondence to assemble a complete, current representation of the dossiers filed with the Confidential .
• Supply Chain Mapping request and information retrieval activities
• Formatted dossiers into Confidential CTD sections.
• Working knowledge of CTD and the ability to assess dossier; Propose regulatory strategies to remediate Gaps

Confidential

CMC Regulatory Scientist Senior

Responsibilities:

• Prepared the chemistry, manufacturing, and controls (CMC) information for worldwide marketing of pharmaceutical and biological products for Global submissions; accurately review and promptly release Regulatory supporting documents /Reports, satisfying registration/ renewals, supplements / variations/ change control processes and responses, as required by regulatory agencies.

QA & CMC Specialist

Confidential

Responsibilities:

• Responsible for all tasks associated with maintaining the Variation Tracking Spreadsheet and assuring that the Product Dossier Manager ( Confidential ) and the Global Product Registration (GPR)/Register systems are maintained.
• Coordinated and performed all logistics related directly to the CMC Translation process.
• The process is inclusive of 15 markets spanning Central and South America.

Quality Assurance / Calibration Specialist

Confidential

Responsibilities:

• Provided complete documentation of all GMP/GLP Equipment
• QA Reviewer for Confidential architect and Lab Equipment Documents
• Technical Support for Confidential -HPLC, LCMS and GC Systems
• Liaison between Confidential and Manufactures
• Responsible for all Lab Equipment and Stability Chambers

QA & C Auditor/ Validation

Confidential

Responsibilities:

• Auditor, Quality Assurance and Compliance, Pre Clinical & Clinical-Gap reg. Areas
• Validation of Computer Systems and Analytical Equipment
• Audited and approved Scientific I/S Application and Infrastructure Documents
• QA Rep for Computer Related Systems (CRS) Validation- single/multi site projects
• Site Contact/ Trainer for CRS Change Management / Change Control/ IS Tool

Project Manager

Confidential

Responsibilities:

• Liaison between Environmental Clients, Regulating Agencies, Contract and Pace
• Provided critical analytical, technical and administrative support to clients
• Reviewed analytical results and quality control data reports
• Compiled validation reports, data packages and deliverables to specifications
• Communicated clients objectives, permit limits and analysis requirements to the lab

Marketing Specialist

Confidential

Responsibilities:

• HPLC and GC Application Tests, and Technical Support; Internal and External Trainer
• Evaluated and confirmed cGxP compliance
• Confidential Part 11 requirements for Confidential, Network and ODBC Systems Architecture
• Tested and validated Client/Server software package for Chromatography (ISO)
• Prepared technical documentation related to validating software for distribution

Senior Chemist

Confidential

Responsibilities:

• Analytical Development
• Stability Testing/ Drug Method Development/ Protocols/ Method optimization
• New Drug method validation and transferring
• Supervisory responsibilities: Training, Data audit/ review, and interviewing candidates
• Complete familiarization with cGMP, GLP, OSHA, FDA and safety guidelines

Analytical Chemist

Confidential

Responsibilities:

• Formulatory and stability testing of drug products via HPLC, GC, Dissolution analysis
• Analytical method development and validation
• Interpreted and analyzed chromatographic data and statistical reports
• Performed testing based on USP and in house methods
• Maintained Quality Assurance and Control as a data reviewer