Contract Quality Management Systems Officer (Gauteng) at Aspen Pharma Group

OBJECTIVE OF ROLE

• The 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 ‘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 and support the Quality department under the direction and supervision of the Quality Lead – Quality Management Systems, to optimise Quality processes and record-keeping, through effective dealings with customers, ensuring compliance with applicable legislation.

KEY RESPONSIBILITIES

General operational activities

• Execute daily tasks and 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.
• Maintain templates and lists
• Maintain accurate filing and retrieval of documentation.
• 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.
• Work with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Maintain good relations and communications with all members of the team and respond politely and in a timely fashion to internal and external customers.
• Serve as an effective liaison and communicate with internal and external customers.
• Display a professional attitude when responding to customers and responding to enquiries in a timely manner
• Utilize systems, databases and trackers to provide accurate information to internal and external customers on request.
• Adhere to deadlines/due dates.
• Escalate to the line manager all possible delays and critical issues.
• Any other duties assigned by the line manager or head of department.
• Perform any other administrative tasks relating to your work as and when required.
• Manage and utilize resources effectively to keep processes cost effective.

Quality Management Systems

• Provide 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.
• Assist with the management of eQMS records in line with standard operating procedures.
• Initiate eQMS records timeously, close eQMS records timeously and ensure that eQMS records comply with guidelines, standard operating procedures, work instructions and policies.
• Follow up regularly on the progress of eQMS records with internal and external customers.
• Record 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
• Arrange upliftment of the complaint sample from the Complainant.
• Courier the Complaint sample to the relevant Manufacturing site/Alliance Partner
• Arrange delivery of the replacement sample to complainant.
• Manage all complaint samples and send for destruction, post investigation, including additional replacement samples
• Perform a reconciliation of customer product quality complaints with internal and external customers.
• Compile, review and update controlled documents in the document management system including standard operating procedures, work instructions, forms, templates and attachments.
• Adhere to good documentation practices and data integrity principles.
• Prepare 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.
• Support the Quality Management Systems Pharmacist with annual product quality reviews, including the schedule, requesting and collating data, and compiling the report.
• Support the Quality Management Systems Pharmacist to compile and update the site master file and quality manual.
• Comply with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) guidelines and regulations.
• Compile the quality systems management review report and quality trend report under the guidance of the Quality Management Systems Pharmacist or Quality Lead – Quality Management Systems.
• Participate in QMS monthly reviews
• Deliver internal training e.g. GxP training and SOP training.
• Facilitate the payment of annual licence retention fees.
• Maintain the training matrix, and training tracker.
• Identify training and development with the line manager.
• Implement training according to personal and team development plans.
• Coordinate upskilling and multi-skilling in line with staff development.
• Complete Change control, Change action, Deviation, Investigation, CAPA, Effectiveness check, Audit Finding records in accordance with the requirements of the QMS due dates

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

• Matric / Grade 12
• Relevant Tertiary Qualification Preferred

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• A minimum of 1-year administrative experience
• Experience in a Quality GxP-accredited pharmaceutical environment, preferably in a marketing authorisation holding entity, distributor, wholesaler or manufacturing facility
• Understanding of pharmaceutical quality matters, legislation, regulations, and guidelines.
• Having attended a quality or regulatory course would be advantageous.
• Computer skills in MS Office suite and Adobe required.
• Experience with electronic quality management systems, and document management systems
• Computer Literate – MS Office