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Job Title: Supervisor Stability Program and APR
Job Location: Shreveport, Louisiana
· Direct oversight of personal and activities related to the administration of the stability program and the annual product review (APR) process.
· Primary reviewer and/or approver for documents including but not limited to:
o Stability protocols.
o Stability data summaries.
o Annual product review data tables.
· Development and performance management of direct reports including: training, coaching and mentoring, goal setting, performance evaluation and feedback and, in association with the Manager, Quality Systems and Compliance and HR progressive discipline.
· Ensures all work is performed and documented according to approved standard operating procedures and test methods, in general compliance with current Good Manufacturing Practices (cGMP) and in a timely manner consistent with agreed upon timelines and schedules.
· Assist the Manager, Quality Systems and Compliance in the collection and use of metrics to monitor the quality, timeliness, efficiency and effectiveness of activities in the laboratory and helps lead initiatives to drive improvement in these areas.
· Assist the Manager, Quality Systems and Compliance in the development and justification of expense and capital budgets and staffing requirements.
- Demonstrated ability to lead and supervise staff in a technical environment. Prior experience in a Supervisory role is beneficially but not essential.
- Minimum Bachelor’s degree in chemistry, biochemistry or a closely related physical or biological science is preferred. Associate degrees or other academic qualification combined with significant experience may be acceptable.
- Knowledge and understanding of cGMP and other regulatory guidance relevant to pharmaceutical stability, annual product reviews and stability testing of pharmaceutical products.
- Understanding of non-sterile (e.g. solid oral dose, antibiotic creams) drug products and the principles and practices related to their manufacture is an asset.
- Effective listening and verbal communication skills.
- Solid written communication skills.
- Stays focused and effective in an environment where time pressure and changing priorities are the norm.
- Ability to effectively utilize computers in the conduct of day to day activities with experience with SAP desirable.
Dr. Reddy's Laboratories, Inc. - 11 months ago