By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.
We have an opening for an Lead Associate, Quality-Complaints in our Princeton, NJ office.
This role will be responsiblefor:
Providing leadership to Dr. Reddy's Laboratories personnel including employee training and development, staffing, goal planning, assigning and directing work to effectively manage the day to day activities.
Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents.
Assess the CAPA effectiveness and provide recommendations for the manufacturing and packaging sites in order to ensure that all corrective and preventive actions are effectively preventing recurrence of identified issues.
Identification of critical complaints that have a potential of causing field alerts or recalls.
Assist in the implementation of recalls and field alerts by writing summaries, and memos, gathering required test reports and data, in order to provide timely correspondence with the regulatory agencies and maintain compliance with those requirements.
Creation of metric reporting to track complaint volume, trends and critical issues in order to update management on the market complaint issues.
Monitor and assist with the daily process of opening new complaint files, assigning complaints, updating the complaints database, tracking complaint investigation status, assisting in the completion of failure investigations, obtaining signatures, generation of responses to customers and filing complaints as required.
Oversee the effective and timely review of incoming product complaintsand Investigationsto ensure that all pertinent technical and medical observations are accurately captured with respect to the product complaint reporting processes.
Suggest strategies to improve complaint processing cycle time, customer complaint processing, investigations and/or customer response processes.
Interfaces with the Pharmacovigilance personnel and MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE.
Interfaces with MICC to ensure that all complaints are evaluated to determine if the event should be reported as an MDR or ADE.
Ongoing support of MIRACLE (changes to processes, and qualification where applicable). Ongoing support and training of MICC. Supports APR processes.
Education & Experience:
Bachelor's.B.S. or M.S. in life sciencesispreferred;chemistry, biology,or Pharmacyetc.
A minimum of 10-12years experiencein a GMP setting of the pharmaceutical or medical device industry
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.