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QA Manager QMS Support

Indianapolis, IN 46268

Posted: 11/21/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 593329 Pay Rate: 160.71 Is job remote?: No Country: United States

Job Description

Pay rate is commiserate with experience and ranges between $100-140/hr
 
Key Responsibilities:
  • Lead and support the adoption of a Document Management System (DMS) within RLT.
  • Collaborate with cross-functional teams to assess the current document management processes and systems.
  • Execute the strategy and detailed project plan for the implementation of the new DMS, including timelines and deliverables.
  • Facilitate the migration of documents from the existing system to the new DMS, ensuring data integrity and compliance.
  • Develop and execute change management strategies to ensure smooth adoption of the new DMS.
  • Provide training and support to employees and stakeholders on the use of the new DMS.
  • Monitor and evaluate the effectiveness of the new DMS and identify opportunities for continuous improvement.
  • Create, manage, and execute change management records in the change management system.
  • Collaborate with cross-functional teams to identify process and quality management system changes.
  • Develop a comprehensive change management plan, including communication strategies, training plans, and stakeholder engagement.
  • Execute the change management plan, ensuring adherence to timelines and deliverables.
  • Monitor and evaluate the effectiveness of the change management process and make recommendations for improvement.
  • Provide guidance and support to cross-functional teams during the execution of change management activities.
  • Ensure compliance with regulatory standards and industry best practices during the change management process.
  • Support additional QMS integration activities as required.

Key Skills and Qualifications:
  • Bachelor's/advanced degree in a relevant field such as Business Administration, Quality Management, or Pharmaceutical Sciences. Certification in Compliance or Quality Assurance preferred.
  • Previous working knowledge of the pharmaceutical landscape.
  • Proven experience as a Business Consultant or in a similar role, preferably within the pharmaceutical industry.
  • Strong understanding of quality management principles, regulations, and standards, including FDA regulations and Good Manufacturing Practices (GMP).
  • Excellent project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.
  • Solid analytical and problem-solving skills, with the ability to identify root causes and develop effective solutions.
  • Excellent communication and interpersonal skills, with the ability to collaborate and influence cross-functional teams.
  • Proficiency in using quality management tools and methodologies, such as Six Sigma, Lean, or Kaizen.
  • Experience managing, deploying non-IT tools and technologies commonly used in quality management, such as document management systems, change management systems, and electronic document management systems (EDMS).

Projects:
  • Adoption of a Document Management System (DMS): The Business Consultant will lead the implementation of a new DMS to streamline document management processes and ensure compliance with regulatory standards. This project may involve assessing current processes, implementing existing strategy and plans to the new system, migrating documents, and facilitating change management activities.
  • Change Management for Process and Quality Management System Adoption: The Business Consultant will be responsible for creating, managing, and executing change management records in the change management system. This includes collaborating with cross-functional teams, developing and executing change management plans, and ensuring compliance with regulatory standards and industry best practices.

Milestones:
  • Completion of the assessment of current document management processes and systems.
  • Execution of the existing strategy and detailed project plan for the adoption of the new DMS.
  • Successful migration of documents from the existing system to the new DMS, ensuring data integrity and compliance.
  • Execution of change management activities according to the change management plan.
  • Evaluation and documentation of the effectiveness of the new DMS and change management process.
  • Continuous monitoring and improvement of document management processes and change management activities based on feedback and performance metrics.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Indianapolis, IN

Ready to kickstart your career in the vibrant city of Indianapolis, Indiana? Look no further! Explore our diverse job opportunities in this dynamic city that not only boasts a thriving job market but also offers a rich blend of cultural experiences, from catching a race at the iconic Indianapolis Motor Speedway to savoring delicious local eats like breaded pork tenderloins. Discover renowned art galleries like the Indianapolis Museum of Art at Newfields, catch a show at the historic Indiana Repertory Theatre or root for the beloved Indianapolis Colts at Lucas Oil Stadium. With picturesque parks like Eagle Creek Park and a bustling downtown scene, Indianapolis is the perfect place to grow both personally and professionally. Browse our job listings today and unlock endless possibilities in this enchanting city!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.