Quality assurance- Complaints Specialist

About the role :

• On-time and GMP
• compliant release of dosage forms
• No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand
• Responsible for complaint management, including entry, follow-ups, product analysis, and closure.
• Develop and establish reports for prompt review of new complaints, regulatory reporting decisions, and follow-up.
• Code events and ensure all required information for a complaint file is obtained and properly documented.
• Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality engineering review.
• Track, receive, and ship products as needed.
• Execute daily complaints analysis and failure investigations, documenting results and relevant information.
• Approve complaints in assigned product families.
• Set up complaint meetings and effectively communicate with worldwide complaint groups and internal departments.

Minimum Requirements:

• Functional Breadth
• 3 y of experience in complaints and investigations.
• QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
• Collaborating across boundaries.
• cleanliness zones.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• Qa (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• English.