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.

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 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.

• 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.

• 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.

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