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Quality Systems and Compliance Contractor

Cambridge, MA 02139

Posted: 12/03/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 616328 Is job remote?: No Country: United States

Job Description

This position will support the Quality Systems and Compliance Quality Systems & Complaince functions in:
  • Management in product complaint handling including but not limited to:
    • Intake of Product Complaints from the secured access mailbox
    • Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & PharmacovigilanceoAssist in providing product complaint metrics reports
    • Develop training on product complaint handling
    • Assist with revision of product complaint SOPs/WI
    • Archive product complaints in accordance with company policies
  • Support Vendor and Audit team with document control tasks•Will support regulatory inspection preparation and onsite during inspections as required
Requirements:
  • B.S. degree in life sciences, chemistry or engineering or equivalent and a minimium of 5 years experience in Pharmaceutical Quality or Regulatory 
  • 1. Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc. 
  • 2. Expereince with GxP regulations inlcuding but not limited to product complaint handling, patient privacy principles, document control, etc. 
  • 3. Experience with Veeva QualityDocs and Veeva eQMS a plus
  • 4. Knowledge of Vendor and/or Audit documentation a plus

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 is an equal opportunity employer. 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 Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

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.