Job Description

Divisional Manager:Quality Assurance - Cape Town, Southern SuburbsFull job descriptionKEY RESPONSIBILITIESStrategy and DevelopmentContribute to the creation and implementation of best practice capacity planning vision, strategy, policies, processes and procedures to aid and improve operational performanceContribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems (QMS)Responsible for achieving budget and forecastOperational management of the QA Department:Drives delivery of day-to-day Quality Assurance activities, ensuring adherence to plan and schedule.Provides advice and knowledge regarding interpreting Good Manufacturing Practice guidelines and regulations.Liaising with suppliers with regards to quality issues and complaints xe2x80xa2 Reviews and approves raw material and finished product specifications.Identify change, increase efficiency, influence decisions and deliver results while ensuring compliance.Provides oversight and works directly in daily operations and systems within the Quality Assurance program to assure completions of activities on time and in compliance to regulatory guidelines.Release compliant products to marketMonitors non-conformances or anomalies to the guidelines and GMP principles and provides timely input to ensure proper completion.Responsible for adherence to an audit program.Assesses and reviews the impact of excursions and deviations throughout the manufacturing and packing process.Maintains internal and external relationships.Assist with training in line with departmental training program when required.Management of departmental budgets in line with organizations financial objectiveAssists Supply chain as and when requiredGood Manufacturing practice (GMP, GLP, GWP)Maintaining and coordinating all GMP principlesConduct risk assessments on a regular basisMonitor and approve temperature excursions during product transportationProvide Regulatory support relating to compliance and all GMP activities that might impact the dossier or SAHPRA/PIC/s.Documentation & Systems ManagementDocumentationManaging the accuracy and completion of all databased entries, registers and formsManages the implementation of new products in line with QA requirementsResponsible for managing deviations, risk assessments and other related documentsWriting and distributing of audit reportsCompiling and presenting management review reports to the EXCOSystemsDrive operational efficiency by ensuring fit for purpose QMSEnsure ongoing compliance with the Quality Management System ISO standardsMonitor overall process mapping for quality improvement purposes.Personnel ManagementSetting up goals and objectives in alignment with Scientific Affairs departmental strategiesConducting Performance management and appraisalsManage conflicts when necessaryMentoring and coaching and developing of direct reportsPRE-REQUISITESB. Pharm registered with the SA Pharmacy Council8- 10 yearsxe2x80x99 work experience in a quality assurance position within a pharmaceutical environment5 years Management or supervisory experience strongly preferred

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