· Technical Proficiency: A robust foundation in engineering, life sciences, pharmaceutical or medical device or related fields is crucial.
· Regulatory Knowledge: Understanding regulatory requirements and standards such as ISO 13485
· Analytical Skills: The ability to analyse data, troubleshoot issues, and find solutions is critical.
· Time Management: Managing time effectively, meeting deadlines, and coordinating with cross-functional teams are key skills for success.
· Communication Skills: Transparent and effective communication is significant for collaborating with teams and communicating with internal and external stakeholders
· Attention to Detail: - High level of accuracy and attention to detail when reviewing documentation, processes, and data to ensure compliance with quality and regulatory standards.
Desired:
- MS Word – Advanced level - MS Excell Intermediate
Job Responsibilities:
· Ensuring Device labelling compliance with approved specifications.
· Ensure Batches are released to the next stage accurately and OTIF - Ensure technical libraries and compliance documentation is accurate and maintained
· Maintenance of customer technical libraries and technical agreements ensuring compliance
· Supportive Document Arrangement: managing batch-related documents such as DOCs and COAs
· Complete actions assigned from QMS assigned CAPA, Change Control, Planned deviation, Risk assessment and document update activities
· AD hoc tasks assigned to assists team - MDR/Technical file compilation support