Quality Assurance Assistant

Job Purpose

Supports the development, implementation, review, and facilitate continual improvement of the QMS bothwithin SA QA and the other business units as required by GMP requirements.
Supports the development, effective implementation and ongoing management of the Standard OperatingProcedure (SOP) System

Accountability
General support of the Quality Management System (QMS)•Supports the effective implementation andmanagement of the Quality Management System(QMS)
•Supports the development, implementation andreview of the QMS both within SA QA and the otherbusiness units as required by GMP requirements.
•Continuously ensures that the QMS complies withlocal/international regulations and best practice.
•To identify and drive process simplification andcross functional integration through the liaison withkey stakeholders.
Manage and maintain SOP/ Policy review and Approval process:
•Manage and maintain the SOP review and approvalprocess via Wrike software.
•Drafts new SOPs for QMS (as applicable), reviewnew SOPs drafted by other team members/ SOPsrequiring periodic revision as well as to review SOPsthat have been updated for QA.
•Review SOPs from other Business units, finaliseand upload to required platforms.
•Building in data integrity principles into all datacollections, reviewing and compiling processes andprocedural controls are put in place to ensure dataintegrity is maintained throughout.
•Keeping the content of the SOP current and aligningit with Cipla India (Global) SOPs as well asSAHPRA and other applicable guidelines.
Continual Improvement
•Identifies new opportunities within the businessunits to continually improve the QMS.
•Captures continual improvement suggestions onthe “Continual Improvement and Risk Management”tracker as per relevant procedure.
QA Training
Training via Learning Management System
•Maintains QA Training Matrix and training recordsfor the department.
•Schedules the QA training and the implementationthereof.
•Provides QA training in areas of competence.
•Provides/ arranges Cipla QA Induction training, asrequired.
•Drives innovation in the provision of QA trainingboth in expanded scope and process employed.
•Evaluates the competency of trained staff againstevaluation requirements, training matrix and SOPs.
•As Tier 1 Administrator, coordinates relevant QAtraining in Learning Management System (LMS).
•Performs all other LMS Tier 1 Administratorfunctions as per SOP requirements.
Review and approval of promotional material and Communication Letters
•Reviews promotional material and launch lettersagainst relevant legislation (Medicines Act,Marketing Code etc.), according to portfolioallocation, when requested by the Management orin the absence of a second reviewer.
Quality Assurance Assistant: QMS
QA Assistant-QMS (v4)
• Escalates areas of risk identified within promotional material item text/imagery, to Director - Quality Operations SA as necessary.
Import/ Export Permits
• Assists with reference and deposit requests for application.
• Assist with the application processes related to import / export of narcotic material, narcotics permits and return of triplicates to SAHPRA as per the required timelines.
QA Reporting
• 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.
Any other reasonable duties
• 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:
o OOS/ OOT Notifications/ Investigations
o Deviations review/ Investigations
o CAPA review/ Investigations
o Temperature Excursions
o External Audit Prep/ Responses
o Report Generation
o Self-Inspections