Quality Specialist

Description

• Education Requirements:
  
  Bachelor's degree preferred. Candidates with Associates degree considered with relevant experience.
• Experience required- 3-5years of relevant experience within quality assurance, quality control, investigation, sample management and complaint management.

• Possesses a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
• Ability to perform routine assignments and develops competence by performing structured work assignments.
• Ability to use existing procedures to solve routine and standard problems.
• Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues.
• Promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.
• Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.
• Readily accepts performance feedback and incorporates this feedback into future performance.
• Learns to use new problem solving tools to solve issues.
• Ability to interpret Quality Policies, Procedures and Guidelines for daily application.
• Developing technical writing capabilities and is able to compile straightforward investigations and procedures.

• Mailbox monitoring-Veeva mailbox to check the task
• Accept the assignment and start with the workflow
• Samples:
  Visual inspection of bottle of tablets, bottles of vaccines
• This role has no exposure to blood products or human samples.

Complaints/Investigations Management:

• Supports the Complaint Management Topic ensuring all product quality complaints (PQC) are investigated within the specified time frames and Corrective and Preventive Actions are identified when required.
• Assess whether reporting to Health Authority is required.
• Performs trending to identify any specific or recurring problems.
• Approves low and medium risks complaint investigations.