Lead Associate QA Stability Program & APR

Description

At Dr. Reddy's "Good Health Can't Wait"

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 for their community and every community.

I.                    POSITION RESPONSIBILITIES

•         Direct oversight of personal and activities related to the administration of the stability program and the annual product review (APR) process.
•          Managers site quality management systems activities 
•          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.
•          With the site quality head, assures that systems and processes, in the following areas, are defined and executed in compliance with cGMP and applicable company policy:

o    cGMP auditing includes hosting and responding to regulatory and customer audits and conducting internal audits of site activities

o    Generation, storage and retrieval of GMP documents and records

•         Manages change control administration
•        Responsible for KPIs associated with document center, training, APRs, complaints, etc,
•          Responsible for periodic/ quarterly management reviews, associated data, KPIs, etc.

II.                    EXPERIENCE

• Demonstrated ability to lead and supervise staff in a technical environment. Prior experience in a Supervisory role is beneficial.
• 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.
• ·    Experience with quality systems oversight (Document controls, training administration, internal/external audit program.
• 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 and SharePoint is desirable.

 Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

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.