Job Description

Division

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Quality

Department

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Formulation

Employment Type

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Permanent

Job Purpose

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To manage Quality Product Complaints and the related digital systems supporting the process.

To ensure Audit Readiness and maintain audit-relevant documentation.

To manage the Quality aspects of Narcotics permits and controls (annual reports etc.)

To maintain Applicant related licences for the site.

To coordinate Self Inspections for GMP related SOPs.

To assist in reviewing non-compliance documents and form part of the Risk Assessment team when required.

To review Promotional Material relevant to the scope outlined in the SOP/Policy and therapeutic area.

To ensure that Cipla Medpro operates in compliance with Cipla's Quality Management System requirements, all of the provisions of Act 101 of 1965 (Medicine and Related Substances Control Act), Act 53 of 1973 (Pharmacy Act) and all Regulations to these Acts, guidelines as well as Good Practice guidance documents pertaining to manufacture, warehousing and distribution of medicines and other health related products.

Accountabilities

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Supports the effective implementation and management of the Quality Management System (QMS)

Review and approval of Non-conformances (NC), Deviations and Out of Specification/Trend (OOS/OOT) notifications

Provides pharmacist expertise on QA Product Complaints/Queries

Pharmacovigilance

Review and approval of Product Quality Review Reports (PQRRs) and Product Quality Review Summary reports (PQRSRs)

Review and approval of promotional material

Reworks, batch inspections and reprocessing

Audit readiness

Stability schedule and reports

System management of Internal CAPA's

Batch Release (Ad-hoc duty: Legal Pharmacist requirement)

General administration and support

Education Qualification

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DipPharm or BPharm degree, registered with SAPC and actively practicing as a pharmacist in South Africa (non-negotiable). Evidence of current Continuous Professional Development for SAPC compliance for the current year.

Computer skills - MS Word, MS Excel both at Intermediate level or higher. High level of written and verbal communication ability in English.

High level of accuracy and attention to detail.

Ability to cope under pressure, stress, high volume workload and adhere to strict deadlines.

Relevant Work Experience

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At least 3 years' work experience in a pharmaceutical company or similar background. Experience in Quality Assurance is required.

Experience in a pharmaceutical or biological APPLICANT setting is preferable.

Experience in a pharmaceutical or biological MANUFACTURING environment is preferable.

Employment Equity

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Cipla is an Employment Equity employer, and this position will be filled based on our Employment Equity Plan.