Division
Quality
Department
Formulation
Employment Type
Permanent
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
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.
Employment Equity
Cipla is an Employment Equity employer and this position will be filled based on our Employment Equity Plan.
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