Quality Assurance Consultant

PharmEng Technology; Çankaya; On-site; TRY 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in Turkey seeks a Quality Assurance Consultant to oversee the implementation and maintenance of the Quality Management System. This role demands at least 5 years of experience in Quality Assurance, strong knowledge of GxP regulations, and excellent problem-solving and communication skills. The successful candidate will manage quality risks, complaints, and change controls while ensuring compliance with regulatory standards. This position offers an opportunity to work with a dedicated team in a dynamic environment.

Qualifications

• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Strong knowledge of GxP regulations and quality standards.
• Ability to work independently and collaboratively in a team environment.

Responsibilities

• Implement and maintain the Quality Management System (QMS) in local affiliates.
• Manage quality risk, complaints, and change controls.
• Conduct training management and oversee local product release.

Skills

Quality Assurance

GxP regulations

Analytical skills

Problem-solving

Communication skills

Team collaboration

Education

Bachelor's degree in Quality Management, Life Sciences, or a related field

Tools

Quality Management Systems

Learning Management Systems (LMS)

Job description

About The Job Quality Assurance Consultant

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, self-inspections, 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 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.