Quality Management Systems Officer (JHB North) at Aspen Pharma Group

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
• Utilise systems, data bases 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 as assigned by the line manager or head of department.
• Perform any other administrative tasks relating to your work as and when required.
• Manage and utilise 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

SOFT SKILLS REQUIREMENTS

• Results oriented
• Systems thinking
• Focused
• Cooperation
• Proactive
• Responsibility & accountability
• Resilience
• Informal and formal communications skills
• Active listening skills
• Flexibility and tolerance for ambiguity
• Transition management
• Capacity for resistance to stress
• Perseverance and tenacity
• Understands the Aspen story
• Aspen knowledge
• Optimism
• Passion
• Curiosity/learning agility
• Self-awareness
• High standards
• Effective planning and organisation skills
• Customer focused – understands the needs and priorities of the customer
• Accuracy and attention to detail
• Manage evolving deadlines effectively with regular feedback, and updates
• Integrity
• Work ethic
• Ability to meet deadlines
• The ability to communicate effectively (written and verbal) is essential
• Sense of urgency
• Information seeking
• Service orientation
• 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.