Product Complaint Manager (FullTime)

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Ensure corporate compliance with government regulations.

Summary

Must interact as needed to ensure overall compliance with government regulations. This may include activities such as: Writing departmental standard operating procedures, and PQS development or review. Other responsibilities include the development of a data auditing program for complaints to insure complaints are being processed according to procedures, tracking of open action items resulting from quarterly meetings and trend notifications, contacting sites on a routine basis to ensure action items are closed. Work directly with sites to implement new quality complaint systems or revise quality complaint existing systems to ensure an effective, efficient and compliant quality complaint process. This can involve identification of resource requirements at the site, establishing local responsibilities and flowcharting the process. Incumbent must identify project management tools for implementation timeline, develop local procedures, create functional forms and documents, and implement approved site procedures and training programs that reflect the implemented system. Provide updates throughout and upon completion of projects.

Qualifications

• BS degree in Pharmacy, Chemistry or related scientific field, or equivalent experience combined with non-scientific bachelor s degree.
• Minimum 8 years experience in the pharmaceutical industry; at least 5 years in a Quality Function; at least 3 years in a technical function such as Regulatory Affairs, Product Development or Manufacturing.
• Knowledge of the FD&C; Act, cGMPs and government regulations for pharmaceutical and consumer products globally.
• Must have excellent use of the English language, with demonstrated ability to communicate in both written and oral formats, and to communicate effectively with all levels of management.
• Strong organizational skills and ability to work on several projects simultaneously is required.
• Experience in interacting with various functional groups at the site level. Ability to effectively address the needs of an operations environment.
• Proficiency in the use of Windows based software including Microsoft WORD, EXCEL, VISIO, OUTLOOK and ADOBE ACROBAT