Quality Management Systems Pharmacist (JHB North) needed at Aspen Pharma Group

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 (SOP’s, 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 maintained
• Change ownership for all assigned change controls and completion of action items
• Complete Change control, Change action, Deviation, Investigation, CAPA, Effectiveness check, and Audit Finding records in accordance with the requirements of the QMS Due dates

Product Quality Reviews

• Compile the PQR schedule based on a risk assessment.
• Compile PQR reports based on raw data provided by the manufacturer (when required).
• Review PQR reports compiled by the Business Supporter/Quality Management Systems Officer for accuracy and compliance to the dossier, technical quality agreement and GMP requirements.
• Identify risks from PQR reviews, escalate such risks to management, and perform risk assessments where required.
• Identify appropriate CAPAs from PQR reviews, notify the relevant department/s to implement the CAPAs and ensure effectiveness check/s are performed.
• Propose and develop methods for improving PQRs.
• Maintain the PQR budget based on schedule

Product Quality Complaints

• Assist with customer product quality complaints in a timely and professional manner.
• Review the accuracy of customer product quality complaints recorded in the electronic quality management system (eQMS) within specific timelines.
• Liaise with the manufacturing sites to ensure that investigations are completed as per specific timelines and requirements.
• Obtain Pharmacovigilance evaluations for Customer product quality within the  required timeframes.
• Perform a reconciliation of customer product quality complaints with internal and external parties.
• Review customer product quality complaint investigation reports
• Evaluate corrective and preventative actions, that have been identified to address customer product quality complaints, for relevance and effectiveness. Identify and escalate any critical concerns that may result in a product recall/withdrawal to senior management.
• Perform a trend analysis of customer product quality complaints to ensure that the appropriate actions are taken.
• Initiate discussions with the relevant stakeholders where trends are observed with regards to customer product quality complaints to implement corrective and preventative actions.
• Generate reports of overdue complaint records and follow up with the manufacturing sites/s every two weeks.
• Assist in developing a robust internal process to handle customer product quality complaints and propose and develop methods for improving customer services.
• Train the relevant employees and third parties on the correct procedures to follow when managing customer product quality complaints.
• Maintain courier costs for complaint and replacement samples

Waste Management

• Facilitate the waste management process (sample destruction) under the guidance of the Quality Lead – Quality Management Systems
• Implement written procedures describing the process for waste management.
• Coordinate product waste destruction, in consultation with the Quality Lead – Quality Management Systems for products/samples
• Liaise with the waste destruction service provider/s relating to waste management requirements

Continuous Improvement

• Identify gaps within current processes, investigate the gaps and propose ways to close the gaps
• Identify ways to streamline processes, resulting in greater efficiency and productivity
• Generate accurate and easily retrievable information and statistics for the department

Requirements
EDUCATIONAL REQUIREMENTS

• Relevant Pharmacy Degree
• Registered with the South African Pharmacy Council

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 3 to 5 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in a marketing authorisation holding, distributor, wholesaler or manufacturing facility
• Experience in Quality Management Systems required
• Experience in medicine legislation, related guidelines and codes of practice
• Experience in Good Manufacturing Practice and Good Documentation Practices
• Computer skills in MS Office suite and Adobe required
• A solid understanding of The Medicines and Related Substances Act 101 of 1965 (as amended) and regulations (South Africa)
• An understanding of SADC and member states’ laws and regulations
• Deep technical knowledge of cGMP, cGDP, cGWP, ICH and PIC/s requirements
• Comprehensive knowledge of SAHPRA and SADC Guidelines
• Experience with electronic quality management systems, and document management systems

SOFT SKILLS REQUIREMENTS

• Results and performance driven
• Sense of urgency – responding to issues and opportunities in a timely manner (Time management)
• Intellectual curiosity – willing to suggest and try new ideas
• Positive attitude and proactive approach to business tasks
• Excellent interpersonal skills
• The ability to communicate effectively (written and verbal) is essential
• Information seeking, effective problem solving and decision making
• Strong capabilities in logical reasoning
• A solutions provider
• Ability to work in a fast-paced international environment
• Accuracy and attention to detail
• Manage evolving deadlines effectively with regular feedback, updates
• Integrity
• Work ethic
• Ability to meet deadlines
• Analytical skills
• Service orientation
• Initiative
• Confidentiality
• Empathy
• Patience
• Influence
• Effective planning and organisation skills and ability to prioritize
• Customer focused – understands the needs and priorities of customers
• Project management skills
• Time Management
• Strong Administrative Skills
• Ability to multitask and strong proven follow-up skills is a requirement.
• Planning, organizing and communication skills.
• Excellent communication skills, including verbal and written proficiency in the English language

COMPUTER SKILLS REQUIRED

• The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.

Apply by

•  01 June 2025