Job title : Deputy Manager - QMS Job Location : Western Cape, Cape Town Deadline : December 08, 2024 Quick Recommended Links Jobs by Location Job by industries Job Purpose To review non-conformance/ Out of spec reports, deviation requests and subsequent correspondence thereof, and drive these to timeous closure.
To Meet regulatory expectations of science- and risk-based product knowledge management by assessing risk in the QMS scope.
Provide Quality Intelligence by compiling, reviewing and analyzing Product Quality Reviews (PQR) on behalf of the Applicant.
To manage the budget and purchase order traffic for Stability and PQR activities.
To evaluate suitability of product for the South African market and recommend process/product improvements based on the reviews conducted.
To review Promotional Material relevant to scope.
To perform Quality Due Diligence on new deals to ensure that quality, technical and business risk are assessed from a QMS perspective and provide the business with final outcome.
Accountabilities QA Process Optimisation and Efficiency QA Reporting Review approval of Non-conformances (NC), Deviations and Out of Specification/Trend (OOS/OOT) notifications Supports the Effective Implementation and Management of the Quality Management System (QMS) Evaluating the suitability of products for South African market, by interpreting data and capturing quality and regulatory aspects in the PQR Report and PQR Summary Report: Stability Review and Temperature Excursion.
Reworks, Batch Inspections and Reprocessing Review and approval of promotional material and communication letters Review and approval of promotional material and communication letters Projects, General Administration and Support Financials, Cost and Budget Pharmacovigilance - Awareness of the Cipla Pharmacovigilance process and provide internal support during Pharmacovigilance audits.
Education Qualification Bachelors degree in a science or technology field (B.Sc/ B.Tech), or other relevant qualification e.g.
Diploma in Quality Management.
Computer skills – MS Word, MS Excel both at advanced/intermediate level.
Ability to navigate unassisted through QMS SharePoint systems and databases.
Relevant Work Experience At least 5 years' work experience in Quality Assurance, preferably in a pharmaceutical company or similar background.
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