MGR QUALITY TRAINING

Quality Product Development Manager

SUMMARY OF POSITION:

Manage a comprehensive Quality Assurance system evaluating, analyzing and reporting on new products and processes relative to the quality related aspects of the new product launch. Provide a structured and systematic review process to assure that the Quality aspects of the product projects meet timelines and meets all regulatory and product conformance requirements prior to market release.

ESSENTIAL FUNCTIONS:

Provide project and product evaluation services to assess the quality of materials, processes, and finished products prior to product launch. Assure, through oversight, that all product quality plans and strategies properly incorporate applicable microbiological, physiochemical, quality system and quality technology.
2. Attendance at all core team meetings to assure a Quality Plan is developed and maintained throughout the new product life cycle. Assist core teams in the presentations to senior management on the status and needs of the core teams.
3. Assure, by audit, that quality system components operate in accordance with corporate policy and procedures and are in compliance with applicable federal, state or local quality system regulations.
4. Assure, by review, that operations properly employ the generally accepted principles of quality assurance to determine and document product quality. Apply the principles of quality control, improvement, planning and assurance to site activities.
5. Lead in the applicatiion of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures. Provide specialized analytical services to aid in the diagnosis and remedy of quality problem root causes.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

Review compendia (USP, FCC, EP, BP, JP) supplements, formularies and develop, update and electronically control Specification.

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to: Director, Quality, Mallinckrodt
Direct Reports: None

WORKING CONDITIONS:

Normal office environment



Requirements:

BS Chemistry or other pharmaceutical related field
5 years or more in QA dealing in bulk or dosage pharmaceuticals, managerial experience preferred. Experience including, but not limited to the following:
Document Control
Customer Inquiries and Complaints
Quality and Regulatory aspect of contract manufacturing
Audits: internal and external, customer and vendor
Product Release
Pharmaceutical Label design

EOE



To apply online, please use the following link: