SUMMARY:

• A challenging position in an organization where I can be an effective link between the customers and the technical management and where I can put my technical and communicative skills to appropriate use.
• I am particularly interested in challenging positions in areas like Quality, Compliance, and Personnel Management where I can be a part of a motivated team responsible for the implementation and enhancement of effective and robust Quality Systems.
• I am looking forward to a position that will make use of my wide - ranging experience in different aspects of Quality, Compliance and Personnel/Facilities Management.
• I bring to the table more than Eighteen years of pharmaceutical industry experience with emphasis on Process, Cleaning, and Equipment Validation, Compliance and Confidential Approval Criteria, a strong understanding of organizational and management relationships, Effective Change Management and experienced in Document Control and Quality Assurance in a Matrix Environment.
• Additionally, I have experience of full ERP system implementation and life cycle management.
• I have a proven career of excelling in challenging environments and have a passion for aggressively learning new processes and technology.

STRENGTHS:

• Customer Service Handling Multiple Projects Analytical Reasoning Attention to Detail Communication Skills
• Working Independently & in Groups Problem Solving Proven Quality Acumen Expertise on Confidential Regulations and Guidelines

TECHNICAL SKILLS:

Computer: SAP QM Module, HPQC, Oracle, Power Point, Microsoft Word, Excel, Access, COLAS, BOHR, HPLC Supporting Software Millennium and Access Chrom, TrackWise, Master Control, Wisdom, GxPharma, Labware, SQL LIMS, Statgraphics

PROFESSIONAL EXPERIENCE:

Senior Manager

Confidential, Cincinnati, Ohio

Responsibilities:

• Responsible for the business process design in their functional area of expertise and adoption of standard ERP functionality
• Strong ability to lead discussions with the business to analyze, configure and model processes in SAP
• Participate in Modifying, testing and validation of system configuration. Revise, review, approve detailed functional specifications for development activities including reports, interfaces, conversions, enhancements, and forms
• Responsible for the functional requirements and solutions (hardcopy and HPQC) for the respective business site/country
• Provide guidance to internal teams on best practices in adopting and integrating SAP QM and cross business client E2E processes (E2E execution - purchasing, logistics, manufacturing, Quality, Sales and Distribution)
• Empower/encourage the Business to embrace multiple ways/procedures to maintain control of product processes and drive alignment to reduce RICEWF (FDS)
• Participate in design decisions on integration with MES, LIMS and Quality modules; embolden “best practice” approach and share past experiences
• Assist with Data Migration working with business and IT
• Provide incite/best practice to the importance in data cleansing and data extraction for migration
• Prepare and present to Business Confidential SAP Global “Blueprint”. Actively engage with business to understand each site’s processes and requirements for appropriate system solutions
• Advise the business for hands-on usage and functionality of function processes
• Accumulate and perform hands on training workshops with personnel based on their roles and responsibilities. Gather and prepare site specific master data for workshop execution
• Global Corporate QM Enterprise Team. Collectively implement Enterprise at Key Confidential manufacturing sites. Coordinate with offshore team members. Multitask and manage multiple deliverables/projects
• 100 percent “Go Live” target dates met with no interruption to business processes
• Provide extended on site (3 months) and remote support for QM SAP Module to ensure “turn key” transition

Quality Assurance

Confidential, Cincinnati, Ohio

Responsibilities:

• Communicate frequently with internal and external Departmental and Management Personnel and Review/Approve/Author SOP’s to maintain compliance to Good Manufacturing Practices
• Prepare, Review and/or Approve written Documents to support Technical Projects, Regulatory Submissions, Change Control and Validation Projects
• Write/Review/Approve Investigations relating to Manufacturing, Packaging, Stability, Laboratory
• Provide the support and oversight of GMP Training activities at the Cincinnati facility. Monitor training compliance and evaluate training effectiveness
• Manage Change Control activities, including Method Validation/Changes, Master Batch Record changes; Oversee changes to Master Specifications and Facilities in order to meet critical project deadlines and Product Launch Dates
• Manage, Review, and Approve Product Complaint Investigations and ensure 100% Due Date Completion
• Supervise Site Stability Program. Ensure Regulatory Stability Protocols and Annual Reports are compliant and processed on time. Work directly with Project/Launch Teams to define registered stability commitments for study design, testing requirements, and stability specifications. Provide Statistical Analysis of Stability Data to create “Action Limits” and “Real Time” Trending Analysis
• Oversee the program for the collation and generation of Annual Product Reviews (APRs). Ensure the timely approval of all APR’s and the continued improvement of the generation process and the effectiveness of the utilization of report contents and data (process capability)
• Administer the Change Control system for Confidential Cincinnati products. Provide the oversight of the review, tracking and approval of Change Controls for the Cincinnati facility. Ensure GMP compliance of changes to documentation, production processes, facilities, methods (and other) as required. Oversee & Maintain the Plant Documentation Archive
• Provide the oversight of Documentation Control activities including the generation, revision or obsolescence of Master Batch Records, Standard Operating Procedures and controlled forms for the Cincinnati facility. Ensure retention of documentation in accordance with regulatory requirements and company policies
• Facilitate the assessments compliance of local/harmonized procedures with corporate standards/policies Monitor the completion of identified gaps
• Manage, train and develop the skills of personnel. Direct the training development and evaluation of employees and conduct interviewing and hiring activities. Ensure employees can function effectively in a team - oriented environment
• Support company, site, and departmental goals. Set goals for group and monitor results and employee performance. Provide direction, interpret policies and ensure work done on a timely basis and in accordance with department and company goals
• Provide design guidance and critical feedback to impacted Business Teams on Study Design, Statistical Analysis and Integrated Analysis Plans
• Assist and advise Regulatory Staff and multidisciplinary Teams with the planning, preparation and timely submission of regulatory documentation
• Review and provide critical input on commercialization activities associated with products including but not limited to submission documents, Process Development Guidelines, Process and Cleaning Validation Master Plans and Global Policy Guidelines
• Function as an effective Quality and Compliance Conduit between the Regulatory Management and the impacted Business units
• Perform other duties as assigned or required by business needs

External Quality Assurance Auditor

Confidential

Responsibilities:

• Verify, through Site Auditing, that suppliers of Raw Materials, Packaging Components, and Finished Goods used in the Manufacturing and Packaging of Products are in compliance with Regulatory Requirements
• Determine, through Site Auditing, that the Contract Laboratories responsible for testing products are operating in compliance with regulatory requirements
• Write and negotiate Quality Agreements with Contract Companies/Vendors
• Ensure, through the timely review of Site Audit Responses, Change Controls, Protocols, procedures and Reports that the Supplier is in compliance with company and regulatory requirements
• Schedule, conduct and report Site Audits in conjunction with Corporate Objectives
• Assess quality systems compliance at Material (API, Excipients, packaging) Supplier, at Contract Manufacturing and at Testing Sites. Assessments include observation of the lay - out and condition of the Facility, Equipment, and Instrumentation, review of Standard Operating Procedures, Validation / Qualification Protocols and associated Reports, Batch Records, Test Reports, and Training Records. Assessment also based upon interaction with contact personnel at Contract Manufacturing / Testing / Supplier Sites
• Independently schedule and execute Audits of Contract Facilities and Supplier Facilities as dictated by the Audit Schedule and Audit Requests. Prepare Reports of the Findings, Review and evaluate the corrective actions based on the Observations, monitor the progress, and ensure expeditious follow - up, as needed. resolve Observations and assist the Supplier/Contractor in development of an effective Corrective & Preventative Action or Quality System Enhancements

Quality Assurance Manager

Confidential, Kalamazoo, Michigan

Responsibilities:

• Interact with Upper Level Management Personnel at Third Party Manufacturers’ (TPMs) as a Confidential representative
• Develop relationships, negotiate issues, and communicate requirements with TPMs
• Interact with many internal business and manufacturing organizations within Confidential
• Assess new TPMs by supporting Due Diligence Audits
• Develop and negotiate Quality Agreements
• Support the establishment and implementation of necessary QA/QC systems with TPMs
• Manage TPMs compliance in Laboratory, Manufacturing, and Packaging functions
• Manage TPMs through routine oral and written communication
• Perform QA support for new product launch projects. Maintain focus on product quality
• Ensure all QA functions have been executed properly by the TPM
• Review TPMs’ Validation Protocols to ensure that Confidential Corporate Standards are met
• Structure Audits to address critical cGMPs
• Assure compliance with Confidential regulatory requirements through Third Party Manufacturing Audits and communication with TPMs. Ensure prompt resolution of TPMs’ Observations
• Review and disposition lots manufactured by TPMs
• Initiate Revision Requests for implementing New Product Test Plans and/or Compendia Changes
• Investigate Deviations / Non - conformance at TPMs and identify Root Cause and Corrective Actions
• Assess priorities and develop plans to assure assignments are completed in a timely manner
• Work on Project Teams and identify critical Quality issues
• Prepare written and oral Reports to communicate effectively with Management on priorities and Quality issues at TPMs
• Write Standard Operating Procedures for various Quality Systems/Processes
• Transfer Production Technology and Analytical Methods to outside Packagers/Manufacturers/Laboratories
• Implement a Third Party Access Database to assist in the management of TPMs

Laboratory Professional, Kalamazoo, Michigan

Confidential

Responsibilities:

• Participate in the Start - up of the new GES Laboratory and in the transfer of Analytical Methods and instrumentation for the laboratory Start - up and cGMP Systems
• Write Investigation Reports, Memos, and revised Analytical Methods
• Consistently meet multiple Product Testing Deadlines
• Perform Analytical Method Transfers to and from the GES Lab
• Perform Active and Impurity Testing per USP/NF and in - house methods on Finished Products and Stability Samples
• Perform IQ, OQ, PQ and Calibration of Analytical Equipment
• Check Laboratory Data Reports
• Review Industry Standards to maintain a cGMP compliant atmosphere
• Train Peers and Superiors on multiple technologies
• Conduct routine maintenance on Lab Equipment

Chemist, Kalamazoo, Michigan

Confidential

Responsibilities:

• Test multiple products for Product Potency using High Pressure Liquid Chromatography
• Perform Stability and Physical Testing
• Design Standard Operating Procedures for Lab Proficiency
• Communicate with Peers and Superiors to meet weekly Customer Service Goals
• Participate in the validation activities pertaining to International Products