Expert Compliance Specialist

2 weeks ago

Hyderabad Secunderabad Telangana, India beBeeComplaints Full time ₹ 1,04,000 - ₹ 1,30,878
Job Description:

We are seeking a highly skilled and experienced professional to join our team in the capacity of Specialist Quality Complaints. This critical role involves conducting complex complaint investigations, ensuring the quality of complaint records, and resolving corrective actions.

The ideal candidate will have a background in the biotech or pharmaceutical industry, with the ability to apply strong analytical skills to evaluate complex situations and prevent potential regulatory issues.

You will be a key player in ensuring our global complaint processes and systems are compliant with internal and external requirements, ultimately driving continuous improvement.

Responsibilities:
  1. Conducting complex complaint investigations and ensuring the quality of all complaint records.
  2. Resolving corrective actions and verifying their effectiveness to ensure the proper level of control for products in distribution.
  3. Executing regulatory and Standard Operating Procedure (SOP) requirements. Anticipating and preventing potential issues with regulators and raising potential quality issues to management.
  4. Applying strong analytical abilities to evaluate complex situations using multiple sources of information. Providing guidance and technical advice, and evaluating assessments from subject matter experts.
  5. Contributing to the end-to-end global complaint process and management system, translating information from the market to drive continuous improvement.
Required Skills and 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).
Benefits:

This role offers a unique opportunity to work in a dynamic environment, collaborating with a talented team of professionals who share your passion for quality and compliance.

As a Specialist Quality Complaints professional, you will have the chance to develop your skills and expertise, working on complex projects and contributing to the growth and success of our organization.

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.

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