Quality Specialist

Novartis; Gauteng; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A global pharmaceuticals leader is seeking a Quality Assurance expert in Gauteng, South Africa. The role involves ensuring compliance with regulations, overseeing product quality, and managing quality investigations. Ideal candidates should be qualified pharmacists with strong skills in GMP and quality systems. Join us in our mission to reimagine medicine and make a difference in people's lives.

Benefits

Comprehensive benefits and rewards

Supportive corporate culture

Qualifications

• Experience in the pharmaceutical industry is beneficial.
• Understanding of GMP regulations and guidelines is essential.
• Skills in planning and organizing are required.

Responsibilities

• Provide quality assurance guidance for operational activities.
• Review batch records and manage product quality.
• Raise and manage quality investigations.

Skills

Knowledge and understanding of GMP quality systems

Analytical thinking and problem solving

High compliance

Communication and interpersonal skills

Education

Qualified Pharmacist registered with the South African Pharmacy Council

Tools

Quality Management Systems (QMS)

Document management

Job description

Job Description SummaryProvide quality assurance expertise guidance and support to operational activities to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.Job DescriptionMajor accountabilities : Batch record review and related activities (e.g. PIT reference standards ordering and management import permit application method transfer sample and temperature checks) for timely market release of finished goods.Product Quality Reviews according to schedule in order to monitor the quality of products and compliance against the marketing authorization.

Compile PQR reports for product renewals.Artwork reviewRaise investigate manage and actively resolve quality investigations as needed e.g. deviations complaints CAPAs non-conformances in conjunction with third parties and operational units to minimize impact on product availability and business.Create and maintain GxP documentationSelf-inspections and supplier / third party assessments according to schedule.

Propose and monitor actions to improve / maintain quality standardsProvide QA / QC support for product launches.Deliver on KPI measures in a timely wayDay-to-day coordination and communication with external functions (e.g distributors analytical laboratory customers)Manage goods for destructionPerform product return evaluations and determine dispositionHandling of technical product complaints .

Training to ensure continuous quality maintenance and quality improvementTake responsibility for corporate citizenship within the sphere of influence and control and to enforce the Company Code of ConductKey performance indicators : Adherence to cGMP and SOPsCompliant product supply and business targets are metNo delay with new product launches caused by QALocal GxP Quality systems in place and maintainedQuality related processes carried out in a timely wayGxP risks proactively identified and effectively mitigatedTraining conducted according to programDelivery of established KPI with regard to quality and performanceTimely close out of Deviations and corrective and preventative actionsCompliance with all aspects of the Code of Conduct / Corporate Citizenship / Novartis Policies and ProceduresMinimum Requirements : Work Experience : Experience in the pharmaceutical industry (quality assurance quality control registration or production) or a directly related field will be beneficialQualified Pharmacist registered with the South African Pharmacy Council.Skills : Knowledge and understanding of GMP quality systems and quality practicesRegulations & GuidelinesDocument managementAnalytical thinking and problem solvingPlanning & organizingHigh complianceCommunication and interpersonal skills.Continuous LearningSelf AwarenessLanguages : English.Why Novartis : Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world.

How can we achieve this With our people.

It is our associates that drive us each day to reach our ambitions.

Be a part of this mission and join us!

Learn more here : receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here : South Africa is committed to promoting equity (race gender and disability) through the filling of this post with a candidate whose transfer / promotion / appointment will promote representivity in line with the numerical targets as contained in our Employment Equity plan.

While we are prioritizing designated groups our selection process will still be based on the most suitable candidate with the necessary skills and experience as outlined in the job description.Skills DesiredAgility Audit Management Business Partnering Change Control Continued Learning Health Authorities Influencing Skills Knowledge Of Capa Qa (Quality Assurance) Quality Management Quality Management Systems (QMS) Risk Management Root Cause Analysis (RCA) Self-Awareness Sop (Standard Operating Procedure) Technological ExpertiseRequired Experience : Unclear SeniorityKey SkillsQuality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO

• Mobile Devices


• Root cause Analysis


• Quality Systems


• OSHA


• Food Processing


• Quality Management


• cGMP


• Employment Type : Full-Time


• Experience : years


• Vacancy : 1