Regulatory Affairs Quality Pharmacist - SA (On-Site) (Gauteng) at Aspen Pharma Group

OBJECTIVE

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring that the Quality aspects of all new Marketing Authorisations and variations from the SAHPRA and Regulatory Authorities of the SADC member states meet intended quality, safety and efficacy requirements as required of the MA Holder, within the committed timelines to ensure minimal disruption to launch and supply.

The role undertakes responsibility for compliance with the Quality Requirements for the New Product Launch Pipeline and the existing   product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan, in support of the Applicant (Pharmacare) License and business requirements, that is in accordance with SA GxP guidelines, the Pharmacy Act, Act 53 of 1974 as amended and the Medicines and Related Substances Act, Act 101 of 1965 as amended.

To perform pharmaceutical tasks within the Quality department under the direction of the RA Quality Lead. This includes the Quality Management System, Vendor Management, Product Quality Reviews, Waste Management, Product Quality Complaints, Inspections, Self-Inspections, , Trend Analysis, Risk Management, Training, Distribution and Wholesale Quality support and associated functions as per GxP and company Standard Operating Procedures.

MAIN DUTIES

• Writing, reviewing and approving Quality documentation, including reports, change controls and deviations.
• Assisting with customer and product queries and quality complaints.
• Assisting with Product Recalls including mock recalls
• Assisting with oversight of Batch release process, including deviation management
• Writing, reviewing and approving Standard Operating Procedures (SOPs).
• Involvement with technical customer queries and product investigations.
• Responding to enquiries in a timely manner, giving advice on quality requirements
• Dealing with the administration and monitoring of the QMS, including change controls, GxP deviations, technical agreements, quality risk assessments, customer complaints, PQRs, self-inspection and external audit reports, and SOPs.
• Assisting with the Vendor Management Process, including third party audits, audit schedules, reports and TQA
• Conducting/assisting with internal self-inspection audits, including setting the annual schedule
• Compilation and reporting on Product Quality Reviews (periodic reviews)
• Participating in regulatory inspections.
• Ensuring that the business complies with current and future GxP standards and requirements.
• Delivering internal training e.g. GxP training
• Responsible for the Waste management process (sample destruction) under the guidance of the QA Lead
• Risk management and risk reporting
• Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
• Working with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Observing and complying with Good Manufacturing Practice (GMP), Good Wholesaler Practice (GWP) and Good Distribution Practice (GDP).
• Observing and complying with company Standard Operating Procedures (SOPs).
• Provide Quality support for the SA and SADC Supply Chain structure as it relates to Distribution and Wholesale matters.
• To ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa
• Conduct root cause analysis and risk assessments and reports
• Participate in QMS monthly and annual reviews
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Interface with Pharmacovigilance, Medical Information, Regulatory and operational departments to ensure audit readiness at all times
• Active collaboration with the Regional and Global Product Quality team, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Ensure compliance with Good Manufacturing Practices (cGMP), Good Storage Practices (GWP),Good Distribution Practice (GDP) as well as compliance with applicable local regulations.
• Perform trend analysis and review for QMS
• Continuous improvement: Identifying gaps within the current processes and investigating and proposing ways to close the gaps; Identifying ways to streamline the processes, resulting in greater efficiency and productivity.
• Compile the QSMR under the guidance of the Quality Lead, which must cover all aspects of the QMS, including Product Quality Complaints, Recalls, Trend Analysis, Vendor Management, Technical/Quality Agreements/SLAs, External Audits Programme, Waste Management, QMS, Batch
• Release and Deviation management, PQR, Documentation, Change Controls, CAPA, Self-Inspection, Training and assessments, Medical/PV compliance issues (incidents), Risk Management, Continual Improvement recommendations
• Support the implementation and management of Electronic Quality management systems 

GENERAL

• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the Quality function while upholding Aspen core values
• Effective management and utilisation of resources to keep processes cost effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by line manager / HOD
• Provide systems and SOPs implementation support for identified Woodmead Departments/Divisions.
• Keep abreast of developments in best practice, inspection trends and all QMS relatedactivities
• Maintain a high and up-to-date level of QMS, auditing, and therapy area of knowledge by attending conference, training courses, reading relevant medical and scientific literature.

Knowledge

•  Computer skills in MS Office suite and Adobe Pro required
• A solid understanding of The Medicines and Related Substances Act 101 of 1965 and Regulations (South Africa)
• An understanding of SADC and member states laws and regulations
• Deep technical knowledge of cGMP, GDP, GWP, ICH and PIC/s requirements
• Comprehensive knowledge of SAHPRA and SADC Guidelines
• Experience with electronic quality management systems

Requirements

SKILLS & ATTRIBUTES: 

• 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
• Information seeking
• Effective planning and organisation skills and ability to prioritize
• Customer focused – understands the needs and priorities of customers
• Project management skills

EDUCATION & EXPERIENCE: 

• Matric
• Relevant Pharmacy Degree or equivalent
• Registered with SAPC
• 3 to 5 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in an MA Holding, Distributor, Wholesaler or Manufacturing facility
• Experience in Quality Management Systems required