Quality Assurance Consultant
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Salary Not Disclosed
1 Vacancy
Job Description
Job Summary: The Quality Assurance Consultant is responsible for the implementation maintenance and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements quality standards and company policies. The Quality Assurance Consultant will manage quality risk complaints change controls deviations CAPA authority inspections selfinspections GxP surveillance product quality reviews training local product release and oversight of GDP requirements for local warehousing and distribution.
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 selfinspections.
- Management of authority inspections and selfinspections.
- 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:
- Bachelors 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 problemsolving 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 resultsoriented mindset.
Employment Type
Full Time
