Quality Specialist

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

Job summary

A leading global pharmaceutical company in Midrand is looking for a Quality Assurance Specialist to ensure compliance with regulatory requirements and internal quality standards. Responsibilities include batch record reviews, product quality oversight, and managing quality investigations. Candidates should be qualified pharmacists with experience in the pharmaceutical industry and a strong understanding of GMP. The role requires analytical skills and effective communication to ensure quality assurance and product availability.

Qualifications

• Experience in the pharmaceutical industry (quality assurance, quality control, registration or production).
• Knowledge of regulations & guidelines.
• Document management required.

Responsibilities

• Conduct batch record reviews and manage related activities.
• Perform product quality reviews and compile PQR reports.
• Raise, manage, and resolve quality investigations.

Skills

Knowledge and understanding of GMP quality systems

Analytical thinking and problem solving

Communication and interpersonal skills

Planning & organizing

Continuous Learning

Education

Qualified Pharmacist registered with the South African Pharmacy Council

Job description

Job Description Summary

Provide quality assurance expertise guidance and support to operational activities to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.

Job Description

Major 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 review
• Raise 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 documentation
• Self-inspections and supplier / third party assessments according to schedule. Propose and monitor actions to improve / maintain quality standards
• Provide QA / QC support for product launches.
• Deliver on KPI measures in a timely way
• Day-to-day coordination and communication with external functions (e.g distributors analytical laboratory customers)
• Manage goods for destruction
• Perform product return evaluations and determine disposition
• Handling of technical product complaints .
• Training to ensure continuous quality maintenance and quality improvement
• Take responsibility for corporate citizenship within the sphere of influence and control and to enforce the Company Code of Conduct

Key performance indicators :

Adherence to cGMP and SOPs

Compliant product supply and business targets are met

No delay with new product launches caused by QA

Local GxP Quality systems in place and maintained

Quality related processes carried out in a timely way

GxP risks proactively identified and effectively mitigated

Training conducted according to program

Delivery of established KPI with regard to quality and performance

Timely close out of Deviations and corrective and preventative actions

Compliance with all aspects of the Code of Conduct / Corporate Citizenship / Novartis Policies and Procedures

Minimum Requirements :

Work Experience :

Experience in the pharmaceutical industry (quality assurance quality control registration or production) or a directly related field will be beneficial

Qualified Pharmacist registered with the South African Pharmacy Council.

Skills :

Knowledge and understanding of GMP quality systems and quality practices

Regulations & Guidelines

Document management

Analytical thinking and problem solving

Planning & organizing

High compliance

Communication and interpersonal skills.

Continuous Learning

Self Awareness

Languages :

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 Desired

Agility 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 Expertise

Required Experience :

Unclear Seniority

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1