Job Title: Quality Assurance Consultant
The Quality Assurance Consultant is responsible for implementing, maintaining, and overseeing the Quality Management System (QMS) in local affiliates.
This role ensures compliance with regulatory requirements, quality standards, and company policies.
Key Responsibilities:
* Implement, maintain, and oversee QMS in local affiliates.
* Maintain local Quality Manual and Site Master File.
* Manage quality risk in local affiliate, including risk identification, analysis, communication, control, and escalation as required.
* Manage complaints, acting as Local Complaint Coordinator for reporting, local assessment, and local investigation.
* Manage change controls, QA assessments, site change controls, QA reviews for change implementation and closure.
* Manage deviations for internal, external, and transport deviations.
* Manage CAPA from deviations, internal audits, external audits, and self-inspections.
* Manage authority inspections and self-inspections.
* Conduct GxP surveillance and assessment locally.
* Manage training, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in LMS.
* Release local products, review shipment performance, goods receipt check, and deviation handling.
* Oversight GDP requirements for local warehousing and distribution.
* Qualify shipping lanes and manage local transport performance of secondary distribution.
* Review secondary distribution transport performance.
* Manage returns, including QA evaluation against return criteria and collaboration with distributors.
* Manage product recalls, including local recall execution, communication with customers, communication with HA, recall reconciliation, and local product destruction.
* Manage GxP suppliers, including supplier identification, qualification, approval, annual compliance status evaluation, quality audit planning, conduct quality audits, and CAPA approval and closure.
* Manage 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 5 years of experience in Quality Assurance within pharmaceutical or healthcare industry.
* Strong knowledge of GxP regulations and quality standards.
* Excellent analytical, problem-solving, and communication skills.
* Able to work independently and collaboratively in team environment.
* Proficient in using Quality Management Systems and Learning Management Systems (LMS).
* Aware of attention to detail and accuracy.
* Strong organizational and time management skills.
* Effective leadership and team management abilities.