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. The Quality Assurance Consultant will manage quality risk, complaints, change controls, deviations, CAPA, authority inspections, self-inspections, GxP surveillance, product quality reviews, training, local product release, and oversight of GDP requirements for local warehousing and distribution.
Key Responsibilities:
* Implement, maintain, and oversee QMS in local affiliates.
* Maintain the local Quality Manual and Site Master File.
* Manage change controls, QA assessment, site change control, QA review 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 local GxP surveillance and assessment.
* Perform product quality review (PQR).
* Manage training, including maintenance of training matrix, training of local staff, annual GxP refresher training, and handling of training assignments in the LMS.
* Release local products, review shipment performance, goods receipt check, and deviation handling.
* Oversight of 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.
* At least 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.
* Able to work independently and collaboratively in a team environment.
* Proficient 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.