QA Lead For Manufacturing/QP
Posted on May 19, 2021 by Elevate Direct
QA Lead for Manufacturing - DS/DP
Established in December 2000, WuXi AppTec (NYSE: WX) is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with operations in China and the United States. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services throughout the drug R&D process. Our services are designed to help our worldwide customers shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions.
WuXi AppTec has successfully established a fully integrated services and technology platform during the past decade. The company built its initial capabilities around discovery chemistry and has further enhanced the integrated services with analytical services, bio-analytical services, process research, process development services, API manufacturing services, DMPK/ADME, discovery biology, pharmacology, formulation, toxicology, genomic services, biologics manufacturing services, antibody and biological research reagent manufacturing and sales, and most recently clinical research and regulatory services.
WuXi AppTec has developed from four founders and a single laboratory in December 2000 to 10,000 employees and 5 million square feet of laboratory and manufacturing space, including facilities under construction. The company is actively improving its capabilities and capacity through new expansions in its global business. Capitalizing on the great advantage of conducting R&D services both in China and in the U.S., WuXi AppTec is building an alternative R&D engine to serve the global life-science industry.
This role will be responsible and accountable for ensuring GMP production quality system in place adhering to all regulatory, cGMP and company requirements. This role will be reporting to the Site QA Head.
Act as site QP to be responsible of manufacturing release of DS/DP and participant in GMP production activities, such as process transfer, validation etc.
Close monitoring the construction quality of GMP production.
Accept or reject finished products, intermediates, and raw materials as necessary. Assure that only those products which have met the established standards and specifications and have been assessed to be fit for purpose by appropriate CoA/CoC to meet market requirements.
Participate in investigation, ensure adequacy of investigations, root cause analysis and corrective and preventive actions, and effectiveness of investigations.
Ensure inspection readiness of the area with respect to all self-inspections, internal and external audits within and external to the company. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, if necessary.
Provide expertise to manufacturing to assure aseptic processing and adherence to all relevant codes, standards, and regulatory requirements.
Work with functional department to create department SOPs and assure alignment with regulatory requirements.
Audit quality documents of functional department to assure data integrity and provide guidance from QA perspective.
Review and approve manufacturing generated documents, include but not limited: qualification plan/report, SOPs, batch records, IPC results, deviation, CAPA, change control, risk assessments etc
Assesses facility and quality systems' state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
Perform tasks as assigned by N+1.
Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC and proven experience acting as a QP in vaccines manufacturing business.
Minimum bachelor's degree in biology, biotechnology, or relevant discipline.
Minimum 10 years of QA experience in the biotech/pharmaceutical industry, preferable in vaccine, CDMO experience also preferred but not required.
Minimum 5 years managerial or leadership experience.
Strong knowledge of legislative, regulatory, market and data integrity requirements.
Strong communication skills with demonstrated ability to work in a Matrix environment.
Strong experience in delivering against operational and strategic business priorities and handling QA activities on a large scale.
Attitude of continuously striving for excellence, and ability to take calculated risk to achieve superior results.
Excellent collaboration skills, together with ability to influence others.
Ability to work independently with tight timelines and multiple priorities in a fast-paced environment.
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