Quality Assurance Consultant

Pharmeng Technology; Cape Town; On-site; ZAR 50,000 - 70,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Assurance Consultant in Cape Town. This role is responsible for the implementation and oversight of the Quality Management System, ensuring compliance with quality standards and regulatory requirements. Candidates are required to have a Bachelor’s degree in a relevant field and at least 5 years of experience in Quality Assurance. Strong analytical, problem-solving, and communication skills are essential, along with effective team management abilities.

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, change controls, deviations, and CAPA.
• Oversee authority inspections and local GxP surveillance.

Skills

Analytical skills

Problem-solving skills

Communication skills

Attention to detail

Organizational skills

Team management

Education

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

Tools

Quality Management Systems

Learning Management Systems (LMS)

Job description

Join to apply for the Quality Assurance Consultant role at PharmEng TechnologyJoin to apply for the Quality Assurance Consultant role at PharmEng TechnologyAbout The Job Quality Assurance ConsultantJob 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 ResponsibilitiesQMS 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 requiredplaint 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.QualificationsBachelor'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 CompetenciesAttention to detail and accuracy.Strong organizational and time management skills.Effective leadership and team management abilities.Proactive and results-oriented mindset.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at PharmEng Technology by 2xSign in to set job alerts for "Quality Assurance Consultant" roles.Cape Town, Western Cape, South Africa 2 months agoCity of Cape Town, Western Cape, South Africa 2 weeks agoCity of Cape Town, Western Cape, South Africa 3 weeks agoCape Town, Western Cape, South Africa 3 days agoCape Town, Western Cape, South Africa 6 days agoQA Lead (Front-End Automation) - Python & Robot FrameworkCape Town, Western Cape, South Africa 2 months agoEpping, Western Cape, South Africa 1 week agoQuality Assurance Specialist at QE ServicesCape Town, Western Cape, South Africa 2 weeks agoCape Town, Western Cape, South Africa 1 week agoCity of Cape Town, Western Cape, South Africa 5 days agoCity of Cape Town, Western Cape, South Africa 3 weeks agoCape Town, Western Cape, South Africa 1 week agoCape Town, Western Cape, South Africa 6 days agoWe're unlocking community knowledge in a new way.

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Quality Assurance Consultant • Cape Town, Western Cape