PROFESSIONAL EXPERIENCE:

Confidential, Shirley, NY

Data Integrity/Quality Management Systems Pharmaceutical Consultant

Responsibilities:

• Completed Project Plan for Confidential Review on Periodic Review and Remediation of Computerized Systems.
• Provided detail Assessment with comments for Periodic Review Audit Risk Assessment Computer Systems Periodic Review SOPs.
• Performed analysis (including new findings and recommendations) of the current Periodic Review (initial 14 systems) as well produced Remediation Report to the CSPR (Computer Systems Periodic Review).
• Actively participated in the Bi - weekly Data Integrity Meetings as well presented numerous presentations in order promote awareness, train and educate Confidential personnel.
• Created Confidential holistic inventory system inclusive of Assessment of Inherent Risk based on Intended Use.
• Helped implement major changes to the Decommissioning, User Requirements Specifications and overall Software Development Lifecycle inclusive of Regulatory Requirement from Confidential (Data Integrity, CSV, Audit Trail, 21 CFR Part 11, Electronic Records and Signatures, GAMP 5, PIC/s (Data Management and Integrity, WHO (Data Integrity), Annex 11 (Computerized System).
• Provided GAMP 5 Categorization and Criticality for all Computerized Systems.
• Identified systems that do not fall within GAMP 5 Categorization.
• Created the Audit Trail Review Forms (for both System Audit Trail Review (SATR) and Data Audit Trail Review (DATR) and SOP for Company Wide Implementation.
• Reviewed the existing CSVMP (Computer Systems Validation Master Plan) and helped contribute to creation of New Master Validation Plan.
• Provided technical consulting towards the creation of Confidential Data Integrity Risk Assessment Program including Major Risk Objectives.
• Created Official Name Change Communication Form and Process Flow for utilization for groups such as HR, Training, Information Technology as well as Supervisors of Various Departments (e.g. Quality Control, Microbiology, Environmental Monitoring, Production, Validation, etc.) when an employee’s Official Name is Changed. This also includes development of Confidential process that ensures Official Name change completion and documented evidence of key systems such as Organizational Chart, Signature Log, IsoTrain employee official name, Confidential employee Official email address as well as Username Credentials for GMP Computerized Systems.
• Provided Technical Assessment of Potential Capital Budget Procurement of Computerized Systems (e.g. Free Weigh).
• Identified key Data Integrity Risks at Confidential as well Remediation (e.g. ability to potentially manipulate changed to official time clock via the time zone in Systems Operating with Windows 7).

Confidential, Foster City, CA

Bio-Pharmaceutical/Data Integrity Consultant -

Responsibilities:

• Focusing on Quality Systems and Regulatory Compliance Systems in the Confidential .
• Performed Full Validation Work, Qualification of Equipment, Full Process Characterization and Test Method Verification (TMV).
• In process monitoring and inspection, wrote and executed Full Process Validation Protocols (IQ, OQ, PQ, PPQ) to Confidential standards and reports, this included the Cleaning Validation and Product Manufacturing Cleaning Validation.
• Ramp up production, quality systems remediation.
• Process improvements, lot release, in process improvements, line clearance, train operators, work with supplies.
• Trained operators, getting production running and stabilized, work with ops to ramp up.

Confidential, Manhattan, NY/Melville, NY

Site Project/Team Leader

Responsibilities:

• Directed Confidential system-wide assessment/periodic review of equipment/software systems for implementation (Lab Systems such as ELN, LIMS and Data Acquisition (e.g. Empower)), gap analysis, remediation and corrective action for the aforementioned system in accordance with United States Pharmacopeia (USP) General Information Chapter 1058: Analytical Instrument Qualification, GAMP 5 and GMP Compliance.
• Directed and Implemented Domestic and Global Quality Systems Standards for Confidential and Sandoz at Fougera (subsidiary) Facility. Fougera Facility Manufactures Commercial Products such as Sterile Products, solid dosage, creams, ointments, etc.
• Conducted Equipment/Software/SOP/Regulatory Systems GAP Analysis and issued Formal Assessment and Periodic Review Report to Executives at Confidential /Sandoz/Fougera.
• Drafted and issued Formal Remediation report and CAPA plan for all gaps and deficiencies.
• Utilized Sparta Systems’ TrackWise for all CAPA Management.
• Additionally, drafted and issued Executive Summary Report and Proposed Budget/Timeline Implementation plan to the Firms Business Units.
• Key Leader on Inter-disciplinary teams (such as Business, Quality Assurance, Quality Control, Manufacturing, Microbiology, Environmental Monitoring, Regulatory units) across Confidential /Sandoz and Fougera sites.
• Directed assessment and periodic review for adherence to internal and corporate Standard Operating Procedures (domestic/global).
• Conducted System wide audit for GMP Compliance, 21CFR Part11, Electronic Records and Electronic Signatures
• Conducted multi-departmental site assessment and identification of operational trends and issues in order to mitigate business risk.
• Successfully completed all Contract Requirements and Business Objectives prior to Official Deadlines and within budget/resource allocation.

Confidential, Hauppauge, NY

Director of Quality Assurance and Regulatory Compliance

Responsibilities:

• Directed the Quality Assurance and Regulatory Compliance departments in all aspects of Quality Systems within QA/QC units for all Commercial manufactured products.
• Created entire Client Based Quality Systems Programs that were catered to not only cGMP’s but also adherence compliance to Confidential Regulations.
• Primary responsibility for all Confidential Regulatory, Internal and New Potential Client Audits and Inspections.
• Experienced in Quality Management System for GMP and Medical Device (for Branded, OTC, and consumer healthcare products) industries including development of required internal procedures in support of ISO 13485, 9000, 9001and 21 CFR Part 820, 21 CFR Parts 11, 210 and 211, etc.
• Directed activities related to Investigations, CAPA’s, GAP analyses and remediation
• Created Training Programs/Systems and deployed them to the entire organization. Personally trained staff in multiple languages (e.g. English and Spanish).
• Responsible for Regulatory Submissions and any formal responses to applicable governmental agencies/regulatory bodies.
• Performed System-wide Gap Analysis and Quality System Plan Remediation/Corrective Action in order to ensure that proper Quality Systems were in place and any issues/deficiencies were corrected/had Confidential plan.
• Provided overall support to ensure GxP compliance within and across all operational sites.
• Augmented the entire Water System Validation, Cleaning Validation and Confidential Program in all Commercial Manufacturing Areas.

Confidential, Fort Washington, PA

Pharmaceutical Consent Decree Consultant

Responsibilities:

• Involved in Computer Systems Validation, Product Quality Management Systems, Complaints, etc.
• Lead person of Consent Decree item that specifically involved Computer Systems Validation, specifically in the area of Adverse Events, Complaints and Global Telephony Systems. Initial project involved major upgrade of Global Complaints Systems after which I was extended two additional times for two additional Consent Decree project items.
• Successfully completed all three Consent Decree projects and finished projects and software systems were release to the client and were in “ Confidential ” status for global company utilization.

Confidential, Omaha, NE/Los Angeles, CA

Chief Consent Decree Consultant

Responsibilities:

• Oversee consent decree initiatives during third party manufacturing assessment in specific technical areas of over Quality Assurance, Quality Control, laboratory and commercial manufacturing equipment and instrument technology as well as applicable software systems.
• Executed assessment timelines which were highly critical, thus more than 100 hours per week billable time had been logged into the client. Each week for Confidential total of about 500 + hours during Confidential one-month period.
• Overall, successfully completed assigned assessment of third party manufacturers for Confidential ’ Global Consumer Healthcare Group within the stringent timelines, which were dictated for the project.

Confidential, Bethlehem, PA

Chief Consultant

Responsibilities:

• Primary Responsibility to interface with the Confidential and Confidential approved auditing firms in response to Consent Decree and manage entire Remediation Team, Project Plans and Deliverables.
• Provided overall support to ensure GxP compliance within and across approximately 30 operational sites within the sterile injectables, aseptic processes platforms, IV products, etc.
• Areas of Key Focus were Facilities and Monitoring Systems, Environmental Control Systems, Microbiological Programs and Clean Room Design/Validation.
• Implemented Standard Operating and Quality System Procedures as well the employee training, to ensure both written and hands on procedural knowledge and course effectiveness.
• Provided overall support to ensure Consent Decree items, including but limited to, investigations, CAPA’s, GAP analyses, remediation activities, timelines, report issuance and communication to key stake holders, firm executives and the Agency.
• Managed activities and overall technical/quality systems for day to day operations of more than 900 employees working at approximately 30 facilities across the USA under Consent Decree. This was inclusive to the implementation of laboratory data systems such as Data Acquisition (e.g. Empower and TotalChrome) as well as Electronic Lab Notebook (ELN)
• Hands on involvement in assessing, creating, approving and implementing process, cleaning & software validation, equipment qualification, room & facility commissioning, Training and various technical writing such as SOPs, Qualification & Validation Protocols, etc. Overall, was in charge of entire remediation activities for numerous facilities, equipment, staff and quality/compliance systems.
• Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.

Confidential, Hauppauge, NY

Director of Quality Assurance and Compliance

Responsibilities:

• Directed entire Quality and Assurance and Compliance initiatives for domestic and international business entities. Directly interface with the drug development and manufacturing key entities such as R&D, Scale-Up, Commercial Manufacturing, Packaging, QC, etc.
• Directly involved with all aspects in starting new Generic Business Unit in China.
• Hosted two Confidential audits during tenure at this firm. Previous Confidential audit, prior to my joining the firm, lasted almost one month and yielded approximately Confidential 40-page report of observations. Primary leader/hosted the next Confidential audit which resulted in Confidential Formal Closeout of all observations issues from the previous Confidential audit, with no further issues.
• The next two audits hosted during my tenure at the firm lasted Confidential total of five days and yielded no written report/no observations.
• Trained all employees involved in QA, QC, Manufacturing, Packaging, Warehousing and R&D.
• In charge of hosting all regulatory audits including Confidential, sFDA (Chinese Confidential ), EPA, OSHA, DEA, etc.
• Established and/or augmented key Quality Systems (e.g. training, validation, change control, documentation, CAPA’s, etc.) in order to ensure successful compliance to all applicable procedures, policies, guidelines and regulations.
• Integral leader on various projects focused on augmenting the overall Quality Culture of the organizations systems and personnel. This included the implementation of Laboratory LIMS and Data Acquisition Systems (e.g. Empower).
• Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.
• Vendor/Supplier and Customer Audits.
• Provided overall support to ensure GxP compliance within and across all operational sites.
• Physical, analytical, and microbiological testing of incoming materials, in-process materials, finished products, R&D sample as well as Method Development.
• Stability studies conducted to support product shelf life.
• International Regulatory Experience.
• Material Import/Export Compliance.
• Inspection of incoming materials, manufacturing, and packaging lines.
• Process Improvement.
• Review and Submission of NDA, ANDA and OTC Regulatory Submissions.

Confidential, Brentwood, NY

Chief Consultant of Pharmaceutical Quality, Compliance and Technical Systems

Responsibilities:

• Created entire company wide Quality Systems (e.g. SOPs, Training Program, Cleaning Validation, DI and USP Waters Systems Implementation and Validation, etc.) in order to create Confidential cGMP environment from scratch for new business operation.
• Created and managed the following groups Quality Assurance and Compliance, Microbiology, Chemistry and Quality Control Labs, as well as Method and Process Development/Validation and Safety.
• Managed entire Complaint Department as well all CAPA/OOS/Investigation Systems throughout numerous Technical and Quality Departments.
• Completed entire set up of Quality Systems/cGMP environment and was significantly ahead of project schedule allowing firm to be audited by Confidential as well as potential clients such as J&J and P&G. Thus allowed firm to manufacture products and generate revenue, six months ahead of projected timelines.
• Act as subject matter expert for microbiological concerns, able to trouble shoot/provide support for issues within manufacturing areas, water systems, filling lines and manufacturing tanks