Senior Quality Associate

7 days ago


East Liverpool, Ohio, United Kingdom Cpl Healthcare Full time

Job Summary:

Cpl Healthcare is seeking a highly skilled Quality Assurance Specialist to support third-party quality operations and ensure compliance with client requirements. The ideal candidate will have experience in quality operations in the GMP environment and a strong understanding of regulatory requirements.

Key Responsibilities:

  1. To perform QA oversight on assigned external suppliers and third parties manufacturing products and ensure they comply with the clients quality standards and legal requirements.
  2. Act as authorized person for release of products for shipment including material status change in SAP.
  3. To review and assess external customer complaints including the evaluation of the complaint investigation.
  4. To monitor and to drive EEM-EMEA CAPA system.
  5. To support QA management in any quality related matter.

Requirements:

  1. Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering.
  2. Experience in quality operations in the GMP environment.
  3. Excellent command of English, other languages are an asset.
  4. Knowledge and understanding of regulatory requirements.
  5. Good knowledge in office tools (e.g. Word, Excel, SAP).

Preferred Qualifications:

  1. Experience in customer complaint handling.
  2. Experience in the negotiation QA contracts.
  3. Experience in QA systems that support Third Party management.
  4. Working experience within a global organization.


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