Associate - QA Operations & Validations

Company: Disability Solutions
Location: Shreveport
Posted on: September 19, 2023

Job 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.Associate - QA Operations & Validations - Shreveport, LA.Purpose: To administer support in collaborating with Quality, Manufacturing, Packaging, Technical Services, and Engineering teams to provide quality oversight of new equipment, systems, and process validation. This position will also assess changes to existing equipment and processes in a pharmaceutical manufacturing DRL Shreveport Plant. Job Requirements:

• Bachelor's degree in a Science, Engineering or a related field with minimum of 6- 8 years' experience in pharmaceutical industry in a technical capacity.
• Experience writing, reviewing, and/or approving validation documents.
• Experience necessary with pharmaceutical process validation, cleaning validation, equipment, utilities, and computer system qualification processes.
• Ability to make sound decisions and provide guidance related to Quality matters on a variety of site projects.
• Demonstrated critical thinking skills with ability to define and investigate problems.
• Strong analytical skills, written and verbal communication skills
• Thorough knowledge of cGMPs and other regulatory requirements in the pharmaceutical industryPreferred Experience:
  • Experience and knowledge with a variety of root cause analysis tools.
  • Demonstrated ability to work with counterparts to accomplish site goals.
  • Must be able to manage multiple deliverables, possess excellent organizational skills, be detailed oriented and possess good follow-up skills
  • SAP experience preferred
  • Vendor managementPrincipal Responsibilities:
    • Reviews, approves, and provides approval as a quality team member for validation and qualification protocols and reports of pharmaceutical process and equipment to ensure:
      • Compliance with cGMP and internal procedures.The protocols are executed as intended and investigated to resolve any deviations.Conclusions are accurate based on the results obtained.
        • Review of GMP documents including but not limited to Change Control documents, Master Batch Records, SOPs, APRs, specifications, or Laboratory Data.
          • Provide quality oversight of the facility and equipment including their calibration through periodic reviews.
          • Contributes or leads site initiatives and quality improvement projects, as well as process, facility, utility, and equipment changes.
          • Knowledge of and experience with applicable Quality Management Systems
          • Assures that systems and processes, in the following areas, are defined and executed in compliance with cGMP and applicable company policy
          • Perform other tasks as assigned by Lead or Management 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.

Keywords: Disability Solutions, Shreveport , Associate - QA Operations & Validations, Other , Shreveport, Louisiana