OBJECTIVE OF ROLE<\/p>\n
\tThe role undertakes responsibility for supporting the pharmaceutical tasks within the quality management systems (QMS) function of the Quality department for Pharmacare Limited, ensuring QMS and company compliance with sound quality assurance (QA) principles and requirements, Aspen Group and Third-Party Alliance partner policies and procedures and in accordance with Good \u2018X\u2019 Practice (GxP) guidelines, The Pharmacy Act, Act 53 of 1974 as amended, the Medicines and Related Substances Act, Act 101 of 1965 as amended, and any other relevant legislation and guidelines relating to the import, export, manufacture, packing, testing, warehousing and distribution of medicines in South Africa and the Southern African Development Community (SADC), thereby ensuring that the products meet the intended quality, safety and efficacy standards and requirements as required of the marketing authorisation (MA) holding entity, Pharmacare Limited.
\n\tTo perform pharmaceutical tasks and support the Quality department under the direction and supervision of the Quality Lead \u2013 Quality Management Systems, to optimise Quality processes and record-keeping, through effective dealings with customers, ensuring compliance with applicable legislation.<\/p>\n
KEY RESPONSIBILITIES<\/p>\n
General operational activities<\/p>\n
\tExecute daily tasks and according to the relevant standard operating procedures and work instructions.
\n\tAdhere to agreed key performance indicators (KPIs).
\n\tSupport the continuous development and improvement of the Quality function while upholding the Aspen core values.
\n\tOperate computer systems by capturing data, printing standard reports, etc.
\n\tPerform reconciliations of data.
\n\tUpdate and maintain systems, databases and trackers.
\n\tGenerate reports as per instruction.
\n\tCollate data for ad hoc requests.
\n\tVerify and interpret the accuracy of data and audit documentation.
\n\tObtain the necessary signatures for all relevant documentation.
\n\tMaintain templates and lists
\n\tMaintain accurate filing and retrieval of documentation.
\n\tManage projects as per guidance from the line manager and within agreed timeframes.
\n\tProvide regular feedback on progress of projects and highlight any issues that require the line manager\u2019s attention.
\n\tAdhere to company policies and procedures.
\n\tParticipate in training programmes.
\n\tWork with all members of staff to maintain and develop the positive progressive culture within Aspen.
\n\tMaintain good relations and communications with all members of the team and respond politely and in a timely fashion to internal and external customers.
\n\tServe as an effective liaison and communicate with internal and external customers.
\n\tDisplay a professional attitude when responding to customers and responding to enquiries in a timely manner
\n\tUtilize systems, databases and trackers to provide accurate information to internal and external customers on request.
\n\tAdhere to deadlines\/due dates.
\n\tEscalate to the line manager all possible delays and critical issues.
\n\tAny other duties assigned by the line manager or head of department.
\n\tPerform any other administrative tasks relating to your work as and when required.
\n\tManage and utilize resources effectively to keep processes cost effective.<\/p>\n
Quality Management Systems<\/p>\n
\tProvide support for quality management system activities, including change controls, deviations, corrective and preventative actions (CAPAs), quality risk assessments, customer product quality complaints, annual product quality reviews, training, product recalls\/withdrawals, self-inspections, internal\/external audits of Pharmacare, regulatory intelligence and documentation such as standard operating procedures\/work instructions and reports.
\n\tAssist with the management of eQMS records in line with standard operating procedures.
\n\tInitiate eQMS records timeously, close eQMS records timeously and ensure that eQMS records comply with guidelines, standard operating procedures, work instructions and policies.
\n\tFollow up regularly on the progress of eQMS records with internal and external customers.
\n\tRecord customer product quality complaints in the eQMS, liaise with complainants to obtain the required information and complaint sample\/s, respond to complainants and close customer product quality complaints timeously
\n\tArrange upliftment of the complaint sample from the Complainant.
\n\tCourier the Complaint sample to the relevant Manufacturing site\/Alliance Partner
\n\tArrange delivery of the replacement sample to complainant.
\n\tManage all complaint samples and send for destruction, post investigation, including additional replacement samples
\n\tPerform a reconciliation of customer product quality complaints with internal and external customers.
\n\tCompile, review and update controlled documents in the document management system including standard operating procedures, work instructions, forms, templates and attachments.
\n\tAdhere to good documentation practices and data integrity principles.
\n\tPrepare the self-inspection program, liaise with the relevant departments to schedule the self-inspection, participate in self-inspections, prepare the self-inspection reports and follow up on the progress of self-inspection findings, and corrective and preventative actions.
\n\tSupport the Quality Management Systems Pharmacist with annual product quality reviews, including the schedule, requesting and collating data, and compiling the report.
\n\tSupport the Quality Management Systems Pharmacist to compile and update the site master file and quality manual.
\n\tComply with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) guidelines and regulations.
\n\tCompile the quality systems management review report and quality trend report under the guidance of the Quality Management Systems Pharmacist or Quality Lead \u2013 Quality Management Systems.
\n\tParticipate in QMS monthly reviews
\n\tDeliver internal training e.g. GxP training and SOP training.
\n\tFacilitate the payment of annual licence retention fees.
\n\tMaintain the training matrix, and training tracker.
\n\tIdentify training and development with the line manager.
\n\tImplement training according to personal and team development plans.
\n\tCoordinate upskilling and multi-skilling in line with staff development.
\n\tComplete Change control, Change action, Deviation, Investigation, CAPA, Effectiveness check, Audit Finding records in accordance with the requirements of the QMS due dates<\/p>\n
Continuous Improvement<\/p>\n
\tIdentify gaps within current processes, investigate the gaps and propose ways to close the gaps.
\n\tIdentify ways to streamline processes, resulting in greater efficiency and productivity.
\n\tGenerate accurate and easily retrievable information and statistics for the department.<\/p>\n
Requirements
\nEDUCATIONAL REQUIREMENTS<\/p>\n
\tMatric \/ Grade 12
\n\tRelevant Tertiary Qualification Preferred<\/p>\n
KNOWLEDGE & EXPERIENCE REQUIREMENTS<\/p>\n
\t\u00a0A minimum of 1-year administrative experience
\n\tExperience in a Quality GxP-accredited pharmaceutical environment, preferably in a marketing authorisation holding entity, distributor, wholesaler or manufacturing facility
\n\tUnderstanding of pharmaceutical quality matters, legislation, regulations, and guidelines.
\n\tHaving attended a quality or regulatory course would be advantageous.
\n\tComputer skills in MS Office suite and Adobe required.
\n\tExperience with electronic quality management systems, and document management systems
\n\tComputer Literate \u2013 MS Office<\/p>\n
SOFT SKILLS REQUIREMENTS<\/p>\n
\tResults oriented
\n\tSystems thinking
\n\tFocused
\n\tCooperation
\n\tProactive
\n\tResponsibility & accountability
\n\tResilience
\n\tInformal and formal communications skills
\n\tActive listening skills
\n\tFlexibility and tolerance for ambiguity
\n\tTransition management
\n\tCapacity for resistance to stress
\n\tPerseverance and tenacity
\n\tUnderstands the Aspen story
\n\tAspen knowledge
\n\tOptimism
\n\tPassion
\n\tCuriosity\/learning agility
\n\tSelf-awareness
\n\tHigh standards
\n\tEffective planning and organization skills
\n\tCustomer focused \u2013 understands the needs and priorities of the customer
\n\tAccuracy and attention to detail
\n\tManage evolving deadlines effectively with regular feedback, and updates
\n\tIntegrity
\n\tWork ethic
\n\tAbility to meet deadlines
\n\tThe ability to communicate effectively (written and verbal) is essential
\n\tSense of urgency
\n\tInformation seeking
\n\tService orientation
\n\tTime management
\n\tStrong administrative skills
\n\tAbility to multitask and strong proven follow-up skills is a requirement.
\n\tPlanning, organizing and communication skills.
\n\tExcellent communication skills, including verbal and written proficiency in the English language
\n\t\u00a0<\/p>\n
\u00a0<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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