Quality Management Systems Pharmacist

Company Description We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE OF ROLE The role undertakes responsibility for 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 ‘X’ 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.

To perform pharmaceutical tasks within the Quality department under the direction of the Quality Lead - Quality Management Systems. This includes the Quality Management System, Product Quality Review (PQR), Waste Management, Product Quality Complaints, Inspections, Self-Inspections, Trend Analysis, Risk Management, Training, and associated functions as per GxP and company Standard Operating Procedures

Key Responsibilities General Operational Activities

• Execute daily tasks according to the relevant standard operating procedures and work instructions.
• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the Quality function while upholding the Aspen core values
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data.
• Update and maintain systems, databases and trackers
• Generate reports as per instruction.
• Collate data for ad hoc requests
• Verify and interpret the accuracy of data and audit documentation.
• Obtain the necessary signatures for all relevant documentation
• Manage and utilise resources effectively to keep processes cost effective
• Provide quality support for the SA and SADC Commercial, Supply Chain, Value Chain, and enablement functions (e.g. Regulatory, Finance), as it relates to QMS matters
• Maintain good relations and communications with all members of the team and respond politely and in a timely fashion to internal and external customers.
• Work with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Display a professional attitude when responding to customers and responding to enquiries in a timely manner
• Manage projects as per guidance from the line manager and within agreed timeframes
• Provide regular feedback on progress of projects and highlight any issues that require the line manager’s attention
• Adhere to company policies and procedures
• Participate in training programmes
• Keep abreast of developments in best practice, and all QMS related activities
• Maintain a high and up-to-date level of QMS and therapy area knowledge by attending conferences, training courses, and reading relevant medical and scientific literature
• Any other duties as assigned by line manager or head of department
• Maintain templates and lists
• Maintain accurate filing and retrieval of documentation
• Perform any other administrative tasks relating to your work as and when required

Quality Management System

• Responsible for quality management system activities, including change controls, deviations, corrective and preventative actions (CAPAs), quality risk management and 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 (SOPs)/work instructions and reports.
• Compile, review and update SOPs and related documentation (e.g. Work Instructions, standard forms, trackers and all relevant Quality Management System documents) related to work function to ensure compliance with the relevant Policies, Guidelines, Regulations and Contractual requirements.
• Identify and introduce new policies and procedures where necessary
• Review of processes (SOPs, Work Instructions, etc) to ensure continuous improvement and the updating of procedures/work instructions to align accordingly
• Write, review and approve quality documentation, including reports, and eQMS records.
• Assist with product recalls/withdrawals including mock recalls.
• Write, review, approve and update standard operating procedures, work instructions and associated documents.
• Respond to enquiries in a timely manner, giving advice on quality requirements.
• Assist with monitoring and reviewing the QMS, including change controls, deviations, investigations, CAPAs, effectiveness checks, quality risk assessments, product quality complaints, product quality reviews, self- inspections, external audit reports, regulatory inspections and SOPs.
• Conduct/assist with self-inspections including compiling the annual self-inspection schedule, compile the self-inspection reports, follow up on the progress of self-inspection findings, and corrective and preventative actions.
• Participate in regulatory inspections.
• Deliver internal training e.g. GxP training and SOP training
• Assist with root cause analyses, risk assessments, risk management and risk reporting
• Comply with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) guidelines and regulations.
• Collaborate with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions.
• Collaborate with Pharmacovigilance, Medical Information and Compliance, Intellectual Property and Dossier Management, and other operational departments to always ensure audit/inspection readiness.
• Collaborate with the regional and global product quality teams, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Compile the quality trend report and quality systems management review report under the guidance of the Quality Lead - Quality Management Systems.
• Participate in QMS monthly and annual reviews
• Compile and update the site master file and quality manual.
• Renew the licenses for the marketing authorisation holder i.e., import and export licence and medical device establishment licence.
• Complete the risk and impact assessments of new/updated regulations, guidelines, policies, regulatory authority communications.
• Inform internal and external customers of new/updated regulations, guidelines, policies, and regulatory authority communications.
• Ensure ongoing Quality and QMS requirements and commitments, as per the latest regulatory authority and PICS and other relevant guidance, is fulfilled and m