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||Princeton, NJ United States
Mgr Product Quality Complaints|
The Manager of Product Quality Complaint develops, implements and maintains the complaint management system in a manner that is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving and responding to customer complaints and other post-market feedback.
The complaint system will pertain to all US Quality Management of finished pharmaceutical and medical device products.
- Manages the receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820)
- Manages process pertaining to contact with healthcare professionals submitting product complaints
- Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements
- Creates complaint, and related CAPA trend analysis reports and submit to management to ensure early detection of potential quality issues
- Gathers data to assist with any potential recall and/or reporting actions
- Participates in internal audits and external quality system audits conducted by the FDA and other regulatory agency representatives
- Monitors complaints for product trends and notify management of events requiring immediate action
- Follow-ups with Sales Reps, Hospitals, Pharmacies and Physicians to obtain applicable information pertaining to reported events
- Works closely with Pharmacovigilance to ensure timely completion of MDR rationales as well as initial, supplemental and final incident reports to FDA and other regulatory authorities within specified timeframes
- Supports Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and busine ss goals and objectives Travel (approximately 10%)
- Bachelors Degree + 6 years of Quality Assurance experience in the pharmaceutical and/or medical device industry
- Experience in analyzing product quality complaints and determining reportability to the FDA and other regulatory agencies
- Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations and documentation
- Excellent analytical, problem solving, and troubleshooting skills
- Proficient in MS Office software, TrackWise
- Strong interpersonal and communication skills
- Ability to work in a team environment
- Ability to multi-task
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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