Quality Assurance Assistant

Overview

Supports the development, implementation, review, and facilitates continual improvement of the QMS both within SA QA and the other business units as required by GMP requirements. Supports the development, effective implementation and ongoing management of the Standard Operating Procedure (SOP) System.

• General support of the Quality Management System (QMS).
• Supports the effective implementation and management of the QMS.
• Supports the development, implementation and review of the QMS both within SA QA and the other business units as required by GMP requirements.
• Continuously ensures that the QMS complies with local/international regulations and best practice.
• To identify and drive process simplification and cross functional integration through liaison with key stakeholders.

• Manage and maintain SOP / policy review and approval process.
• Manage and maintain the SOP review and approval process via Wrike software.
• Draft new SOPs for QMS (as applicable), review new SOPs drafted by other team members / SOPs requiring periodic revision as well as to review SOPs that have been updated for QA.
• Review SOPs from other Business units, finalise and upload to required platforms.
• Build in data integrity principles into all data collections, reviewing and compiling processes and procedural controls are put in place to ensure data integrity is maintained throughout.
• Keep the content of the SOP current and aligning it with Cipla India (Global) SOPs as well as SAHPRA and other applicable guidelines.

• Identifies new opportunities within the business units to continually improve the QMS.
• Captures continual improvement suggestions on the “Continual Improvement and Risk Management” tracker as per relevant procedure.

• Training via Learning Management System.
• Maintains QA Training Matrix and training records for the department.
• Schedules the QA training and the implementation thereof.
• Provides QA training in areas of competence.
• Provides/ arranges Cipla QA Induction training, as required.
• Drives innovation in the provision of QA training both in expanded scope and process employed.
• Evaluates the competency of trained staff against evaluation requirements, training matrix and SOPs.
• As Tier 1 Administrator, coordinates relevant QA training in Learning Management System (LMS).
• Performs all other LMS Tier 1 Administrator functions as per SOP requirements.

• Reviews promotional material and launch letters against relevant legislation (Medicines Act, Marketing Code etc.), according to portfolio allocation, when requested by the Management or in the absence of a second reviewer.
• Escalates areas of risk identified within promotional material item text/imagery, to Director - Quality Operations SA as necessary.

• Assists with reference and deposit requests for application.
• Assists with the application processes related to import/export of narcotic material, narcotics permits and return of triplicates to SAHPRA as per the required timelines.

• Facilitates the collation of all data required for the compilation of Monthly and Quarterly QA Reports.
• Compiles the Monthly and Quarterly QA Reports as per the specified due dates.
• Compile reports and presentations as and when requested by QMS Management.

Assists with any reasonable duties as requested by QA management to ensure that the department is functioning optimally and meeting its set objectives and goals. These could include the following activities:

• OOS/OOT Notifications/Investigations
• Deviations review/Investigations
• CAPA review/Investigations
• Temperature Excursions
• External Audit Prep/Responses
• Report Generation
• Self-Inspections