Deputy Manager - QMS

at  Cipla

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.

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.