Marisol Freytes Email & Phone Number

United States

● Participate +21 on-site and virtual audits and work +18 audit questionnaires according to 2023 schedule.● Lead on-site vendor audits to assess the capabilities and potential services that could be provided by third parties. This will include auditing services or products such as analytical laboratory services, calibration services, computer software, Depot, excipient, primary and secondary packaging, Commercial Medicinal Products (wholesalers), preventive maintenance services, medical device, service software between and Direct-to-Patient between others.● Assist in the performance of internal and customer audits, when requested.● Ensure all vendor information is up to date and accurate in the Veeva Vault application. ● Issuance of Technical Agreements, Audit Reports, Risk Assessments, Scorecards, and CAPA actions related to the supplier program.● In-depth understanding of GxP (GMP, GLP, GDP and GCP), ISO17025:2017 and ISO9001:2015 standards; and 21 CFR 210, 211 and knowledge on Part 11 guidelines.● Perform first shipments approvals for Depot Services (Distributors of Almac Clinical Products).● Traveling, as needed

Pennsylvania, United States

Titusville, Nj

● Coordinate completion of Quality Agreements and Specification Agreements with global suppliers.● Perform actions associated with Change Control and CAPA/Assessment Plans using the Trackwise program.● Support Suppliers Risk Assessments, trending and annual review evaluations. ● Author documents in DocSpace applications.● Provide updates to Supplier Records on behalf of account owner (Spoc).● Support global supplier quality management activities. ● Support documentation activities for delisting of suppliers.● Perform assessment for leveraging existing audits.● According to schedule, request surveillance audits.● Coordinate and work on assigned task/projects with different Global suppliers and team members (Global Procurement, Subject Matter Experts (SME), Spocs at Global locations (I.e. USA, Belgium, China, South America), and Contract Auditors for a related coordination(s) and/or contacting supplier per established priorities.

Skillman, Nj

• Update packaging specifications CAPA(s) associated to manufacturing locations.• Standardize a Global Supplier Master List • Document activities and relevant information in TrackerOne (report program), and interact with QA and suppliers to obtain supporting information for packaging materials.• Work with different team members (Manager, Procurement Specialists, Subject Matter Experts and/or QA) notifying supplier changes, related coordination(s) and/or contacting supplier according to established priorities. • During meetings, provide status updates of delegated activities.

West Point, Pa

Participate in the product transfer documentation review process from different corporate sites to the new client. The areas in consideration are manufacturing, packaging, logistics, quality and analytical. The documentation to be compiled includes specifications, bill of materials, batch records, validation documents, specifications and other data, as applicable.

Fort Washington, Pa

• Participate in the Draft review process for the applicable Packaging Development and Assessment Plan (PDAP), Packaging Line Trials (PLT), and Packaging Development Reports (PDR). • Support of existing packaging personnel’s projects, where appropriate, with short term reassignments to free up McNeil personnel for development of acceptable processes and procedures on the package development area. Includes revisions on Standard Operating Procedures (SOPs), gap-analysis and supplemental specifications. • Due to work on a Consent Decree environment, provide support on the binders assembling process.

West Point, Pa

• Work as cGMP Lead Auditor in supplier audits. Includes report write-ups, evaluating different systems: company’s quality systems, the facility and equipment system, the materials system, the production system, the packaging and labeling system, and the laboratory. Also, evaluate the vendor corrective actions. The suppliers audit to be performed compass raw materials manufacturers, distributors, and contract laboratories in USA. • As the auditee, provide escort and documentation support during third parties inspections (ISO inspections) and second party audits where approximately twenty (20) client audits are received per year. • Review and approve customer specifications in order to commit to client standards and requirements.• Provide cGMP training to new hires and personnel, as required.• Perform internal audits to the different manufacturing Plants (Dry Dispersion, Wet, Lake and PVAP Plants). This includes receiving, sampling, manufacturing, packaging, laboratories (raw materials, finished good and micro labs), shipping and warehouse areas. The internal audits shall meet company’s procedures and comply with IPEC standard and some 21 CFR Part 210 & 211 requirements. Based on the observation(s) from final report, open, evaluate and close applicable corrective actions in the Oracle system. • Monitor and Revise the Pest Control program and Temperature & Humidity control charts.

Collegeville, Pa

• Create, review, edit, and issue technical documents including Purchase Specifications/Testing Standards for raw materials as part of an SAP project.• Review compendial changes, supplier’s Certificate of Analysis (C of A) and any other supporting documents to create/edit specifications.• Maintain periodic review of the documents. Utilize GMP experience to ensure completeness, accuracy, and compliance of the documents. • Identify issues and comply with Standard Operating Procedures and associated job aids. Keep a tracking system for the review and approval of specifications. Update tracking system daily for documents during drafting, approval, and completion process.• Coordinate review and approval process from the early commentary stage through the final approval stage. • Maintain files and complete detailed project work as assigned. • Create a workflow and lines of communication between departments and different sites when documents are reviewed and approved.• Handle urgent and critical requests within a timely manner. Supports the ongoing responsibility of keeping technical documents in compliance with cGMP and corporate requirements.

King Of Prussia, Pa

• Compile stability data located in different electronic systems: Control Document Management System (CDMS), Biopharm Laboratory Management System (BLIMs), electronic Experiment System (eExperiment), Quality Standards documents and Protocols to generate projects stability tables for the submission of clinical trials as per GMP requirements.• Develop and edit technical documentation (usually user oriented) supporting data processing technology, and conduct audit reviews for writing understanding and logic.

• Establish a Quality and Documentation System in compliance with Good Storage /Distribution Practices, 21 CFR Part 210 & 211 standard and Drug Enforcement Administration (DEA). Some of the procedures generated covered the following areas: Engineering area (calibration system, pest control, preventive maintenance, security alarm systems, Air Conditioning Units (HVAC) automation process including temperature and humidity monitoring, General Warehouse area (Receiving, Merchandise Placement, Confirmation, Packaging through hand scanners and Delivery to Pharmacies) and Quality area (GMP’s, Change Control, SOP’s and Forms Preparation, Drug Recalls, Complaints and Training Matrix between others). Includes English/Spanish translations. • Establish a Training Program and provide training to Control Substance and General Warehouse team groups.

Caguas, Pr

• Active owner/participant in finalizing the revision and development of Supplier Audit Program. Draft detailed audit plans that include; activities, outcomes, indicator and budget. • Work as GMP Lead Auditor executing and generating audit reports for more than twenty external suppliers per year. The suppliers in scope were active ingredients (API), raw materials, packaging components, distributors and contract laboratories at USA, Latin America, Asia and Europe. Special projects performed, as required.• Prepare and coordinate annual vendor/supplier audits schedule (due diligence, maintenance and for cause audits due to investigations) for Quality Compliance Department. Interact with various vendor / suppliers from Puerto Rico, United States, Latin America and Europe. Also, submit and evaluate paper audits and reports.• Provide training to the supplier audit team group.• Provide site support for FDA inspections and client audits.• Perform internal audits evaluating manufacturing/packaging/laboratory facilities to assure compliance with internal practices, FDA and other regulatory agency requirements.• Support on the follow up of CAPA system and Complaints system.