To carry out the day-to-day operation and supervision of over 50 production personnel involved in manufacturing of product for the facility. Maintains general control to ensure compliance with domestic FDA/GMP and all international regulatory requirements. Responsible for ensuring compliance is maintained in the area concerning environmental, health and safety practices. Directs and oversees Leads and employees to accomplish established objectives.
Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
This is an opportunity to work in a high-performing team with exposure to business leaders, provides support for merger & acquisitions, joint ventures, investments and other strategic transactions, as well as provide employment law counseling and other general legal advice to the businesses.
The role of Quality Engineering is integral to the on-going compliance of the manufacturing processes. The Senior Quality Engineer is responsible for ensuring compliance of our products and processes throughout the product lifecycle, including development, manufacturing, and post-market in medical device regulated environment.
Lead and facilitate the development of new ophthalmic equipment products in accordance with defined cost targets and within defined schedule and budget constraints
This role is primarily responsible for the ensuring compliance to FDA & Other regulatory bodies for the External Manufacturing Business
Manages activities and supervises support personnel associated with document control to provide documentation support to all areas of the plant for SOP's, specifications and batch records.
Provides site leadership and coordination of Change Control processes to assure conformance with B&L requirements and maintenance of records associated with change control activities. Works closely with all site and regulatory personnel and management in effecting complete, thorough and regulatory compliant implementation of desired changes.
Develops and coordinates training programs and procedures to effectively assure personnel are sufficiently trained to perform required job functions. Creates a training environment that promotes employee training and utilizes resources to assure successful training programs.
The Quality Auditor – Suppliers will have responsibility for supplier audit planning, scheduling, execution, documentation, reporting and follow up.
Perform specific duties according to SOP's within the VS3 Assembly/Packaging Department, either by the use of both hands or by using machinery when assigned.
Responsible for the assembly and/or manufacturing of single use, surgical components to create finished goods SKUs in the VS3 Assembly/Packaging area.
All work performed must be completed with the highest Quality standards possible and within the allowed time given in order to maintain the highest efficiencies possible with minimum requirements established for each operation.
Work schedule: Monday - Thursday; 6:00 am - 4:30 pm. Must be able to work overtime as needed, including Saturday's and Sunday's.
Serves as a primary technical advisor in Analytical Sciences for analysis of pharmaceutical active ingredients, excipients, and topical drug products. Enhances the company’s capability in analytical method development/validation and trains others. Organic chemistry working knowledge to recognize potential degradation pathways, drug-excipient interactions, and structure elucidation of unknown degradation products / impurities to support pharmaceutical development is desirable. Experience in applying ICH guidelines to ANDA and NDA submissions for dermal drug products is a plus. Has good communication skills, is well organized and adept in identifying key project steps and corresponding timelines/deliverables. Monitors the scientific and financial progress of assigned projects. Prepares protocols and technical reports. Ensures that laboratory work under the job candidate’s direction is scientifically sound and meets project objectives. Experienced in GMP and GLP, working with regulatory agencies for successful NDA and ANDA submissions.
Plan and manage/coordinate activities related to ophthalmic medical device product development projects throughout Surgical R&D using the global PDP (Product Development Process), allied systems and tools.