Deputy Manager

1 week ago

Cape Town, South Africa Cipla Full time

**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
- 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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