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.
Responsibilities:
- 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.
Requirements:
- 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.
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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.