January 22, 2025

Job Title: QA Responsible Person

Location: Austria (Remote/Flexible)

Hours: 0.3 FTE

My client, a global CRO, are seeking a highly motivated and experienced Responsible Person to join their team. As the Responsible Person, you will ensure that their products comply with all regulatory and quality standards, with a focus on maintaining the highest levels of product safety and compliance in the market. Your role will be critical in overseeing the quality and safety of products, and you will be responsible for coordinating all quality-related activities.

Key Responsibilities:

  • Product release on the market: Ensure timely and compliant release of products
  • Quality issues impacting internal warehouse processes and supply: Address and resolve any quality issues affecting operations
  • Deciding on the final disposition of returned, rejected, recalled, or falsified products: Make informed decisions regarding the handling of problematic products
  • Approving any returns to saleable stock: Approve returned products for re-entry into saleable stock when appropriate
  • Evaluation of customer complaints and non-conformities classified as major/critical: Assess and take appropriate action on major/critical complaints and non-conformities
  • Coordinating and promptly performing any recall operations for medicinal products: Manage the process of product recalls in compliance with regulations
  • Quality-related contact with local authorities: Serve as the point of contact for quality-related communications with regulatory authorities
  • Supervise Risk Assessment: Oversee risk assessment activities to identify and mitigate potential risks to product safety and quality
  • Host inspections performed by Local HA/Partners/HQ when Client Austria is inspected/audited: Facilitate and manage inspections conducted by local authorities, partners, and headquarters

Qualifications:

  • Proven experience in a quality assurance or regulatory role, preferably in the pharmaceutical or healthcare sector
  • Strong understanding of product release processes, quality management systems, and regulatory compliance
  • Excellent communication skills with the ability to liaise with local authorities and internal teams
  • Detail-oriented and capable of making informed decisions under pressure
  • Experience in risk assessment and managing product recalls is a plus
Experience
Proven experience in a quality assurance or regulatory role
Work Level
Mid-Level
Employment Type
Part Time, Remote
Elysabeth Yates
View profile
Industry
AL Solutions
Phone
+44 (0) 203 597 2868 +44 (0) 203 597 **** Show

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