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Johnson & Johnson Consumer Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Validation Specialist II -24-month contract to be based in Guelph, Canada.
Johnson & Johnson Family of Companies touches more than a billion people's lives every single day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and OTC products.
Are you interested in joining a team that is helping improve patient and customer care and drive innovation? Apply today!
Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of a new entity within New Consumer Health and your employment would be governed by New Consumer Health's employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by New Consumer Health at an appropriate time and subject to any necessary consultation processes.
The Quality Specialist II (Validation) will support and co-ordinate activities associated with cleaning, manufacturing and packaging processes, computer systems, analytical and microbial method, shipping, facility, utility and equipment validations for the Guelph site.
The Quality Specialist II will coordinate the development, creation, review and approval of qualification and validation documents (protocols, reports, validation assessments, technical reports, and user requirements, function and design specifications).
They will ensure that documented evidence exists to provide a high degree of assurance that processes, equipment, computer systems and methods are consistently reproducible and meet Johnson & Johnson and McNeil policies and quality standards, health, safety and environmental regulations, and regulatory requirements (e.g. Health Canada and the United States FDA).
The Quality Specialist II will collaborate with Johnson & Johnson Consumer and OTC North American stakeholders to develop and administer validation policies, including the deployment of these policies.
Responsibilities:
Review, revise or approve validation documents (ie. assessments, documents, protocols, reports, etc.) to ensure they are in compliance with relevant SOPs, government regulations, and company policies. This includes documents executed at McNeil Consumer Healthcare - Guelph Campus and /or specific business partners and contract sites. Validation types may include but are not limited to: packaging validation; cleaning validation; process validation; analytical and microbial method validation; shipping qualification; equipment qualification; and computer validation.
Represent Quality & Compliance on taskforces / committees for base business projects. Connect with SMEs as appropriate to ensure transfer of knowledge and action on key deliverables.
Create, review and/or approve other site documents, such as: GCC assessments, Annual Product Quality Reports (APQR), Master Batch Records, Bill of Materials, SOPs etc.
Other responsibilities:
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