Specialist Quality Complaints

Specialist Quality Complaints

Responsibilities

• Complaint Investigation:

  Conduct complex complaint investigations and ensure the quality of all complaint records.

• Corrective Actions:

  Resolve corrective actions and verify their effectiveness to ensure the proper level of control for products in distribution.

• Regulatory Compliance:

  Execute regulatory and Standard Operating Procedure (SOP) requirements. Anticipate and prevent potential issues with regulators and raise potential quality issues to management.

• Evaluation & Guidance:

  Apply strong analytical abilities to evaluate complex situations using multiple sources of information. Provide guidance and technical advice, and evaluate assessments from subject matter experts.

• Continuous Improvement:

  Contribute to the end-to-end global complaint process and management system, translating information from the market to drive continuous improvement.

Qualifications

• A Doctorate degree, or a Master's degree with experience, or a Bachelor's degree with extensive experience, or a Diploma with a substantial background in Quality Complaints.
• Experience in

  quality and manufacturing

  within the

  biotech or pharmaceutical industry

  is highly preferred.
• The ability to oversee multiple projects simultaneously and consistently deliver high-quality results on time.
• Familiarity with basic

  project management tools

  .
• An understanding of applicable manufacturing and testing processes (e.g., API, Drug Substance, Drug Product, Packaging).

Competencies

• Problem-Solving:

  The ability to analyze complex situations and negotiate a position after receiving feedback from multiple sources.

• Organizational Skills:

  Excellent skills in handling workloads and managing multiple priorities.

• Collaboration:

  The ability to operate effectively in a matrixed or team-based environment.