Quality Assurance Consultant

Job Description

Key Responsibilities

• QMS implementation, maintenance, and oversight in local affiliates.
• Maintenance of the local Quality Manual and Site Master File.
• Quality risk management in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
• Complaint management, acting as the Local Complaint Coordinator for reporting, local assessment, and local investigation.
• Change control management, QA assessment, site change control, QA review for change implementation and closure.
• Deviation management for internal, external, and transport deviations.
• CAPA management from deviations, internal audits, external audits, and self-inspections.
• Management of authority inspections and self-inspections.
• Local GxP surveillance and assessment.
• Product quality review (PQR).
• Training management, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.
• Local product release (local QP), shipment review of transport performance, goods receipt check, and deviation handling.
• Oversight of GDP requirements for local warehousing and distribution.
• Shipping lane qualification and local transport performance of secondary distribution.
• Secondary distribution transport performance review.
• Return management, including QA evaluation against return criteria and collaboration with distributors.
• Product recall management, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.
• GxP suppliers management, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.
• Local repackaging and relabeling, including change management, protocol, execution, QA review, and release.
  

Qualifications

• Bachelor’s degree in Quality Management, Life Sciences, or a related field.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Strong knowledge of GxP regulations and quality standards.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in using Quality Management Systems and Learning Management Systems (LMS).
  

Key Competencies

• Attention to detail and accuracy.
• Strong organizational and time management skills.
• Effective leadership and team management abilities.
• Proactive and results-oriented mindset.