Anita Wiest Email & Phone Number

Quality Consultant with Operations experience. Focus on GxP regulated industries - quality auditing, remediation, compliance and training or education

Basel, Baselstadt, Ch

Role added to expand knowledge and experience in other areas of the organization utilizing current skills and technology understanding to create more self-driven programs and possibilities.

Basel, Baselstadt, Ch

o Conduct external supplier audits for PAI, for-cause, baseline, routine, etc. and internal compliance and verification audits. Including packaging, expcipient, API, Drug Products (sterile and non-sterile), computer system, analytical laboratories, and other GMP type suppliers. o Provide support to and manage positive relations with internal sterile and non-sterile sites for pre-approval inspections (PAI) by organizing “Mock” inspections, inspection readiness for regulatory visits, support activities and training of site personnelo Develop and ensure accuracy of audit reports and action items, as well as work with local internal site quality teams to evaluate and determine effectiveness and completeness of audit responses (CAPA plans)o Support the development, implementation, and maintenance of Global procedures, both strategic and tactical, to achieve and maintain compliance, continuous improvement and quality operations by ensuring compliance with worldwide GXP regulations and guidelineso Communicate findings to internal and external teams o Ensure implementation and establishment of appropriate timescale for corrective action plans as well as determine the adequacy of responses; resolve unsatisfactory responses o Prepare for Pre-Approval Inspections by organizing “Mock” inspections, inspection readiness visits, support activities and trainingo Support interactions with regulatory authorities related to quality and compliance policies, guidelines, and systems

Charlevoix, Mi, Us

Accounts: Philip Morris USA, U.S. Smokeless Tobacco Co., John Middleton Co., Altria Group Retail Merchandising Developmento Sales and Marketing business development lead consultant who analyzes and identifies growth opportunities both for clients and internal organizationo Sole cross-functional communications expert managing customer relations and interactions with internal software engineering and quality assurance engineering groupso Development and implementation of new process solutions and innovations to grow business within client and internal organizations across departments o Develop processes and procedures, as well as the materials used to train internal company and external clients on new plans o Manage multiple technical projects and project teams with comfort and ease as well as associated expectations and timelines for production implementationo Continually adapt to new environments and clients as required with business needso Highly developed communication skills and ability to work independently on self-managed projects

New York, New York, Us

Analgesics and Respiratory Unit - Advil, Robitussin, & Dimetapp Brands o Lead and implemented multiple corrective actions to US FDA inspectional findings and corporate auditso Sole site investigator leading multiple quality manufacturing system investigations throughout the majority of the supply chain in a fast-paced environment o Developed and implemented new or updated standard operating procedures (SOPs) based on OTC regulation standards or manufacturer/supplier quality system and product quality auditing standards; communicated standards to production and all other site personnelo Solely responsible for leading investigations (manufacturing, and OOS), negotiating between operations and quality, and determining root cause for events related to consumer complaints, packaging, and manufacturing of consumer OTC drug productso Gathered, recorded, and reported on operational quality events in production, and communicated solutions and preventative actions to cross-functional groupso Responsible for leading decision making regarding timely disposition of impacted products needed to fill customer orders; maintain Right First Time metrico Implemented corrective and preventative actions to reduce future events and maintain metrics to communicate effectiveness and solutions o Performed audits of manufacturing equipment and environment to verify compliance with manufacturing operating procedures

New York, New York, Us

Topicals Unit - ChapStick, Preparation-H & Anbesol Brands o Managed all equipment installation, operational, and performance qualifications (IQ/OQ/PQ) and re-qualifications and revised reporting structure to enhance the process and reduce resource requirementso Utilized effective communication skills to direct and implement low-cost process improvement solutions and initiatives resulting in improved packaging and manufacturing processeso Managed and coordinated day-to-day activities including: statements of work, risk and cost-benefit analysis; project management; process design and development; capital management and budgeting; effective, motivational, and influential communications; developing cross-departmental and supplier relations; implementing automated engineering solutionso Measured results against expectations for project effectiveness goalso Revitalized campaign for waste reduction of production materials (reduced Material Variance by $20,000 in two months; by 82% in half a year)

New York, New York, Us

Respiratory Unit - Robitussin, & Dimetapp Brandso Managed all equipment installation, operational, and performance qualifications (IQ/OQ/PQ) and re-qualificationso Implemented low-cost process improvement solutions resulting in improved packaging and manufacturing processes for Robitussin and Dimetapp brandso Measured results against expectations for project effectiveness goalso Integrated several cross-functional positions into one, based on limited resources and need of business unit for technology savvy, effective, influential communicator with process design, computer, and automation experience

Salem, Va, Us

Developed and implemented portions of a Strategic Business Plan for first-to-market product. Designed and presented effective and persuasive presentation to Venture Capitalists; generated funding for launch of new product (Only team out of three competing to receive funding).

Team lead for development of a new computerized device for reviving dead neural cells. Coordinated and organized all communications between sponsors and team.Promoted and translated device capabilities through formal proposal to sponsors and Biomedical Discovery Challenge group.

Developed a Competitive analysis and marketing strategy for marketing new dental implant device for growth market in U.S.

Masters Of Business Administration, Marketing And Finance

Bachelor, Mechanical Engineering; Biomedical Engineering