main responsibilities:
member of site lead team.
develop and define the technical goals, expectations and deliverables for the plant with lead team members and lead their successful implementation.
own the validation activities through the integrated validation master plan and be responsible for execution of all validation activity.
own the qppa report and deliver on time and in full
own the annual product review activities and deliver on time and in full.
ensure that all ms&t deliverables (e.g. revalidation plan, pfd’s, pqe, etc) are developed, actioned, updated and delivered on time and in full.
ensure that products and processes at the manufacturing sites are in control, capable, compliant and continuously improving (c4i). use lean six sigma to drive improvements.
active membership of the gplot for insulin products.
ensure there is an effective ms & t training programme in place for the plant employees and conduct the training on time.
identify ways to improve information sharing within the organization and beyond.
ensure that the ms&t input into monthly and quarterly reports are delivered on time
maintain an active network with other technical groups e.g. ema cm, insulin steward, corporate ms &t. own the site regulatory activities with regard to export markets
required qualifications:
graduate in pharmacy .
significant experience in technical and quality functions within a manufacturing plant, ideally in parenteral products
Status: Close
Job sub category: Jobs in Cairo, 6th of October - Egypt
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