Patrick Howard Email & Phone Number

United States

• Performed responsibilities of the Director of Document Control for 3 months• Lead specialist to 3 direct reports• Trained new hires on the Veeva EDMS process.• Manage the Veeva EDMS workflows for new hires and oversees the assignment of reviewers / approvers for GXP documentation at 5 Resilience sites.• Ensure training LMS activities meet organizational goals.• Utilize Smartsheets to manage the process for the creation, review, approval, and issuance of GXP controlled documents.• Support the development of corporate policies and procedures for document control and records management.• Track training metrics on a monthly basis to ensure new hires have completed the required training.• Update training documents and Veeva system requirements as SOPs are revised.• Develop user requirements and contributes to the configuration, validation, implementation, and lifecycle management of the corporate electronic document management system (EDMS)• Review the format and metadata of new documents to ensure compliance to approved templates, procedures and EDMS requirements.• Provide guidance to new hires, document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assists users with EDMS workflow related issues.• Act as document and records management subject matter expert during Client audits and regulatory inspections• Provide training to users for document control processes.• Manage the periodic review of controlled documents and partners with document owners to ensure periodic reviews are completed within the required timelines.• Manage and maintain Resilience document templates and partners with site QA document control teams to implement revisions.• Provide document management metrics for Quality Management Review• Contribute to the continuous improvement of the Resilience Quality Management System

United States

• Provide support of day-to-day operations of the Quality System department for multiple sites and support internal and external customers.• Track and trend compliance paperwork (deviations, change controls, etc. both internal and external)• Generate standard operating procedures and/or guidelines to define and improve quality system functions.• Ensure organizational charts are updated on a regular basis.• Participate in continuous improvement initiatives.• Participate in the internal audit program.• Conduct periodic review and audits of Quality Systems• Assist with preparation of QMS metrics.• Master Control – Electronic Document Management System (EDMS)o Manage and administer system ensuring compliance with global regulations.o Work with functional areas to streamline the Master Control processes (preparation, collaboration, review, and approval of controlled documentationo Identify and implement process improvements. o Train new users in use of Master Control• Training Programo Manages employee training program and periodic review of all training files.o Updates Training Matrices for all GXP employees; creates and maintains employee training files; assists with group training.o Oversee training documentation and compliance metrics through use of learning management system (LMS)o Assist with employee “on-boarding” training on general quality specific procedural requirements.o Create and modify user groups, training items, curricula, group trainings and assignments.

• Conduct international regulatory reviews related to food and pharma.• Maintain a working knowledge of global regulations and findings source regulations efficiently.• Manage product regulatory programs as a product steward.• Determine regulatory status of products and complete documentation/registration efficiently.• Provide EHS&R support to product development teams.• Ensure compliance with local, state, federal, and international regulations.• Provide regulatory support for specific food and pharma regulations pertinent to the customer’s product lines.• Non-conformance issues & internal/external audits• Reviewing packaging and product claims/substantiations• Determine regulatory status of products.• Monitor regulatory changes to assess business impact and ensure continued compliance.• Third Party verified to the responsible distribution program through the NACD.• ISO 9001• Compiles, edit, maintains, coordinate, and review regulatory documentation for inclusion of submission to FDA and other regulatory agencies.

• Assist new hires with training requirements. • Maintain the central, controlled supply of cGMP documents originating within the company.• Update and maintain documents, as well as other databases, and perform data entry for tracking documents.• Review documents to determine distribution requirements and process per set procedures.• Support quality systems with CAPA, deviation reduction, continuous improvement, and cross training• Work with primary originators of document to translate the document into written form.• Issue document change requests and document status reports; write departmental SOPs.• Ensure format of cGMP documents are correct, clear, and consistent.• Cross trained in Quality Assurance, Manufacturing and Regulatory Affairs Department• Ensure that documents are written, edited, reviewed, and approved to meet established deadlines.• Lean training orientation

• Perform supervisory duties of employees under my control.• Prepare detailed aging reports for Fire & Security• Payment reconciliation by check, credit card, EFT etc.• Assist with internal audits; maintained audit records and reports.• Serve as a medium for resolving disputes.• Ran and analyzed ageing reports.• Verify validity of open invoices and credits issued.• Contact customers for payment, set-up new customers.• Liaison between staffing company

Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Bachelor Of Business Administration - Bba, Business Administration And Management, General

Associate Of Science - As, Computer Science