Global pharmaceutical concern is seeking candidates to ensure quality standards are achieved and maintained at third-party manufacturers (for API, GMP-intermediates and GMP Starting Materials) and commodity API, Excipient and Bio-material (raw materials for Large molecule manufacturing) suppliers.
Evaluation, development and management of quality systems at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-material manufacturers by conducting audits, by performance monitoring and implementing development programs and by installing quality agreements
Coordinate Quality Project summaries and Project review within Janssen Supply Chain.
Responsible and accountable for the quality of products produced by third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-materials manufacturers (including change management, deviation and complaints handling, validation)
Handles issues, by personal intervention and /or appropriate delegation within the organization to drive to resolution. Fields actions, recalls, compliance audit observations etc. may be among the escalated topics that require his/her involvement
Effectuates and permanently maintains inspection readiness at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, Excipient and Bio-materials manufacturers. Supporting of third-party manufacturers and API suppliers during regulatory inspections and audits and during the development of corrective action plans.
Bachelor & Master degree in Chemical/Biochemistry/Chemical Engineering or related field.
In-depth knowledge of cGMP and other applicable regulations of the different regulatory authorities (for API as well as Excipient and Bio-Materials)
Working knowledge of analytical chemistry, microbiological test methods, chemical processes as well as Bio-material manufacturing processes. Able to apply this knowledge in combination with quality system requirements to evaluate and (if applicable) to lead the development of quality systems at the different third-party manufacturers
Demonstrates strong knowledge of Quality Management competencies such as auditing, quality engineering, root cause analysis, FMEA, design control, project management, specification and stability management
Cost sensitive in managing own expenses and finding the 'right balance' between Q&C needs and effective implementation costs for the quality development of the third-party manufacturer.
Please visit our website, www.Manpower.co.za to submit your CV directly or to view other jobs.
Please note that only shortlisted candidates will be contacted. If your profile is not shortlisted, we will place your CV on our database and contact you as soon as a suitable position does become available. You are welcome to contact us to discuss other job opportunities.
ManpowerGroup SA is the global leader in contingent and permanent recruitment workforce solutions. We provide the agility businesses need with a continuum of staffing solutions. By leveraging our trusted brands, we have built a deeper talent pool to provide our clients access to the people they need, faster. We effectively assess and develop skills, keeping our associates ahead of the curve, so they can get the jobs done each time, every time. ManpowerGroup SA was established in the South Africa in 1999, and today works with organisations in both the public and private sectors, ranging from small and medium-sized enterprises, to multi-national organisations. ManpowerGroup
SA has a network of 7 local branches and is a subsidiary of ManpowerGroup, with a worldwide network of nearly 4,000 offices in over 80 countries and territories. ManpowerGroup SA is Level 1 BBBEE certified.