Melvin Colón, Mem, Msmc Email & Phone Number

United States

Westborough, MA, US

New York, New York, US

Performed DI assessment of client’s manufacturing and QC processes. Performed the gap assessment of the Deviation, CAPA, OOS SOPs, complaints investigations, process validation protocols, and packaging validation. Assessed OOS and deviations of products in expiry. Cambridge, MA Performed the review of Common Technical Document Module 3 for compliance and.

Performed a Data Integrity evaluation of the Common Technical Document of ANDAs submitted and the new ANDA to be submitted to the US FDA.

Hyderabad, Telangana, IN

Perform QC Analytical batch record certification, including reviewing and assessing incidents and OOS.

Performed MOCK audit, prepared the site for an FDA Pre-approval Inspection, Led the backroom during FDA inspection, and supported the site in writing FDA regulatory observations.

Lead MODA-EM implementation; Responsible for the issuance of the Environmental Monitoring trend reports, Site Readiness and Lead backroom activities during Biological License Application audit (EMA and FDA)

New York, New York, US

Performed a Data Integrity Assessment of cleaning procedures and forms.

Provided coaching and GxP Guidance. Performed GMP Audit and Gap Assessment, GMP Training, Reviewed and Rewrote SOPs, Issued Engineering Investigations, Issued and closured of CAPA, Wrote and supported Change Control completion against current FDA regulations and current guidance documents and/or remediation, implementation, including training, and.

New York, New York, US

Performed a Data Integrity Gap Assessment of the purified water system and defined the corrective actions to be taken.

Responsible for the recruitment, development, and day-to-day management of Quality resources required to perform the pharmaceutical site start-up plan. Led design, development, and implementation of quality policies and procedures to meet work plan requirements. Represented the site during FDA inspections.

Support the transaction from clinical to commercial manufacturing. Lead the Document and Label Control Remediation Workstream. Lead Label Software (BarTender) and Document Management System Implementation (MasterControl). Lead Batch Production Record, and SOPs improvement initiatives including the Quality Manual.

Support API Start-up. Provide guidance for Quality System Implementation.

Perform Batch Record Certification (Sterile Process) which included the review of all associated COA, Analytical Raw Data, Lab and Manufacturing Investigations, Manufacturing and Packaging process.

Lead the review of backlog Manufacturing and Packaging records and CAPAs. Reviewed and approved manufacturing investigations. Performed assessment of the batch record review process and lead the remediation activities.

Richmond, VA, US

Manage the review of GMP documents associated with the construction of a new facility. The documents included are: SOPs, Change Controls, and Qualification Protocols.

Richmond, VA, US

Performed gap assessment on OOS and OOT investigations. Managed the Site Remediation and the Batch Record Certification Project.

Atlanta, GA, US

Performed Facilities and Utilities Baseline Assessment. Provided guidance to QC Lab on OOS and OOT investigations.

Irvine, California, US

Lead consultants performing the Laboratory Analytical Data and Laboratory Investigations prospective and retrospective review process. Communicate findings to client management and lead remediation activities.

Richmond, VA, US

Responsible for reviewing and assessing analytical methods validation, similarity testing, release, and stability data for a new Biosimilar drug.

Performed a gap assessment of the Change Control and Validation Quality Systems, developed a mitigation plan, and a remediation plan, guided management on how to accomplish the project. Act as QA responsible person by reviewing and approving all documentation generated on the remediation activities. Coached management on how to avoid the recurrence of the.

February 2018 – April 2018Lead the remediation of the Vendor Management Program work stream. Remediation included SOP remediation, gap assessment to current quality agreements, and assessment of all vendors/suppliers to ensure they meet new requirements. Review Quality Agreements with Vendors, Lead Suppliers Investigations, Supplier Quality Oversight.

Assessed Quality Systems vs. Internal Quality Standards and Dietary Supplement Regulations and lead remediation activities. Implemented Quality System, coach QA Management on regulatory requirements, and help the site change their Quality Culture. Improved Quality Systems by developing SOPs required and revising existing SOPs. Mentor and train site.

Lead the Quality System implementation at the new Brazil site by assessing the GMP activities to be held at the site, developing a project plan, and lead the implementation of the plan. Some of the activities included the managing Senior QA Specialists, the review and approval of Policies, SOPs, Validation Documents (qualification of the facility.

Establish validation engineering policies for a major segment of the company. Interpret, execute, and/or recommend modifications to company-wide policies. Perform work that involves in-depth investigation of subject area, definition of scope, selection of areas of investigation, and development of novel concept. Conceive plans and conduct engineering.

Responsible for the review and approval of Commissioning and Qualification protocols of the expansion project.

PK

Provide GMP guidance during the installation of new packaging lines, cleaning remediation, process validation, packaging process validation, among other GMP activities. Activities included the review and approval of GMP documents such as Packaging Commissioning and Qualification Documents, Process Validation Protocols, Cleaning Validation protocols.

PK

Site Under Consent DecreeOversee and provide regulatory guidance and mentoring to site management and Consent Decree TeamsLead External verification Process Act as the liaison between site management and third-party contracting firms. Participate in Risk Assessment Meetings as QA responsible (Q9)Responsible for auditing documents related to the work stream.

Site Under Consent DecreeParticipated as QA SME during the external verification process.Act as the liaison between site management and third-party contracting firms. Ensure Quality Systems are effective and reliable.Oversee and provide regulatory guidance during the Project Strategy, Change Controls and Validation Master Plan development.

Site Under Consent DecreePerformed internal audits and presented findings to QA Management.Responsible for the review of Investigation Reports.

Manage the implementation of PAT Initiative in the QA/QC department (Q8, Q9, Q10).Evaluate and develop SOP’s related to PAT process, Real Time Release, Batch Record Review, Annual Product Review, Trending, CAPA, Quality Risk Management, Tablet Defects Sampling Evaluation, LIMS, Laboratory Investigations, Internal and External Audits, and Investigation.

Develop Investigation Reports due to failures during the packaging and manufacturing process. Create and manage CAPA’s.Investigate and respond to Customer Complaints.Review Cleaning Trends and Develop Cleaning Validations for packaging lines and manufacturing processes.Review SOP’s and Train operators.

Audit Quality Systems such as Preventive Maintenance, Calibrations, Validations, Change Controls, Work Orders, and SOP’s. Evaluate findings and provide guidance to resolve FDA observations.Develop trainings and train personnel in GDP’s.

Managed the transference of several molds from different suppliers in the US to one supplier in Puerto Rico

Site under Warning Letter Audit Quality Systems such as CAPA’s, Non-Conformances, and Complaints. Provide feedback from compliance point of view to Quality Systems. Evaluate CAPA’s, Non-Conformances and Complaints to assure compliance. Present to MRB findings and resolutions to the audit performed. Implemented a CAPA system.

Manage the Audit of the IL site. Manage the Gap Assessment audit of the Quality Systems, development of an Equipment List, Product List, Gap Assessment to validations performed in the past 3 years, Process Mapping, and Risk Assessment. This exercise will be used to determine compliance and further actions to be taken.

PK

Site under Warning Letter. Review and approval of Change Controls of QA/QC, Technical Services, Engineering, IS Analytical Laboratory, Microbiological Laboratory and Manufacturing areas. Review and approval of Validation Documentation of all areas (Facilities, Utilities, LIMS, IS, QC Labs, PAT, and Packaging). Review Quality Systems and provide guidance to.

Review of Commissioning and Qualification Protocols (Packaging lines, Facilities, Utilities) Development of Commissioning Plan, Commissioning Protocol, Functional Requirements, Software Requirements, Validation Plan, Qualification Protocol for a Clean Steam Generator. Manage resources allocation, metrics and timelines.

Develop and execute Qualification protocols for WRO, WFI, Tanks, and CIP. Develop Validation Plans for Utilities and Manufacturing Equipment. Develop and execute Qualification protocols for Water Reverse Osmosis, Water for Injection, Tanks, CIP, and Clean Steam. Develop. Supervise Validation Specialists and provide support to their activities. Meet with.

Site under Concent Decree- Develop Validation Plan, Change Control Plan, Document Management Plan and Computer Qualification Protocols for the migration of BPCS software in a new iSeries (AS/400).

Project Manager of $4 million dollars and $1.5 million dollars projects for the construction and validation of four new coating suites and modification of a coating room respectively. Develop the validation schedule; coordinate all activities related to validation. Recruiting validation personnel. Decision maker of validation activities. Develop and.

FDA pre-approval inspection & upgrade audit program implemented to identify & correct potential FDA compliance gaps of a biotech plant. Validation of Biotechnological manufacturing equipments based on PAT. (Vessels, Tanks, Agitators, Autoclaves, Refrigerators, Filtration Units, Heat Exchanger, Bioreactors, WFI, SIP, CIP, IQ/OQ/PQ and CSV, System Life.

Pennsauken, New Jersey, US

Develop a Bottle Standardization project and its validation, Review of Batch Records according to CFR 21 Part 11, 210, 211.

Rahway, New Jersey, US

Develop Turnover Packages and Commissioning for a new facility

Develop and execute IQ, OQ, and PQ Validation Protocols for Freezers, Refrigerators using a Kaye Validator, Vial Filler Machines for Lyophilization Process, Water Bath, Balance. Perform Cleaning Validation of Lyophilization machines. Manage of resources allocation, metrics, Validation Plan. Coordinate Validation activities and facilitate and coordinate the.

US

Develop and Execute IQ, OQ and PQ for Air Handling Units.

Develop and execute of protocols for Cleaning Validations, Walk-in Coolers, AHU, Coater Machines, Compressing Machines, Capsule Filler Machines, Metal Detectors, Computer System Validations, Sorting Machines, Oscillators, Cappers, Validate Facilities and Utilities (Manufacturing Rooms, Compressed Air, Fire Alarm, Lighting, Vacuum, Dust Collector, Potable.

Developed and executed manufacturing and packaging equipment, facilities, utilities, CSV, IQ/OQ/PQ protocols, process validation protocols and reports related to the manufacturing area (tablets/capsules). Participated in the validations of transfered products.Prepared and revised manufacturing standard operating procedures related to executed protocols and.

Audited manufacturing and packaging batch records and related documentation for lot disposition.Participated in the decision making related to compliance in manufacturing and packaging processes.Supported and actively participated in procedures (SOP's) revisions.Assisted manufacturing/packaging Improvers and Assurers in investigations due to in-process.

Supervised, organized and scheduled laboratory duties.Finished product and raw material reviewer and approver.Audit laboratory data, logging and validate finished products and methods.Analyzed finished, raw material, validations and stability product and using USP, EP/BP, JP and Searle procedures.

Analyzed raw material using USP, and McNeil procedures.Analyze in-process and finished product samples

Master Of Science Degree; Master, Manufacturing Competitiveness

Master Of Engineering, Engineering Management

Bachelor Of Science Degree; Bs, Industrial Chemistry