Contract Business Supporter (Gqeberha) (Port Elizabeth) at Aspen Pharma Group

OBJECTIVE OF ROLE

• The role undertakes responsibility for administrative support for the pharmaceutical tasks within the Quality Assurance (QA) function of the Quality department for Pharmacare Limited, ensuring company compliance with sound quality assurance (QA) principles and requirements, Aspen Group and Third-Party Alliance partner policies and procedures and in accordance with 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 SADC, thereby ensuring that the products meet the intended quality, safety and efficacy standards and requirements as required of the MA holding entity, Pharmacare Limited..
• To perform administrative pharmaceutical tasks and support the Quality department under the direction and supervision of the Quality Lead – Quality Assurance

KEY RESPONSIBILITIES

General Operational Activities

• Execute daily tasks and work instructions according to the relevant SOPs.
• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the Quality function while upholding Aspen core values
• Operate computer systems by capturing data, printing standard reports, etc.
• Perform reconciliations of data.
• Update and maintain databases.
• Update and Maintain Trackers
• Edit and format SOPs as associated documentation as and when required
• Generate reports as per instruction.
• Collating data for ad hoc requests
• Verify and interpret the accuracy of data and audit documentation.
• Ensure that all relevant documentation gains the necessary signatures for completion.
• Maintain accurate filing and retrieval of documentation
• Perform any other administrative tasks relating to your work as and when required
• Effective management and utilisation of resources to keep processes cost effective

Customer Service

• Responding to enquiries in a timely manner
• 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, cross-functionally, to maintain and develop the positive progressive culture within Aspen

Training

• Assist with training of on QA Departmental SOPs
• Maintain training matrix for the QA Department.
• Assist with routine/ non-routine competency assessments of staff of the QA departments

Quality Management Systems and GxP Compliance

• Observing and complying with GxP requirements (e.g. GMP, GWP, GDP, GLP, GDP, etc) as outlined by guidelines, the company Policies, SOP’s, processes and written instructions in all tasks and activities
• Complete all records and reports timeously and accurately as described in the relevant SOPs, protocols and associated documentation
• Ensure that products are handled according to the required SOPs and documentation
• Complete Change controls, change actions, Deviations, CAPA, Effectiveness checks, Audit Finding records in accordance with the requirements of the QMS Due dates
• Manage the Deviation inbox.
• Log, Assign and track Deviation on the Deviation Tracker and eQMS
• Upload Executed documentation in eQMS

SOP Management:

• Assisting with updating and uploading of required SOPs/ Work Instructions/ SFs for the Quality Assurance Dept
• Assist with Compilation or ensuring compilation of work instruction or SOPs if gaps are identified or change in/new processes identified for the QA Department.
• Format editor for QA Department SOPs to ensure it complies with format requirements

Master Documents:

• Upload relevant master documentation onto electronic document management system
• Enforce implementation of document management processes as per procedure.

Vendor Management:

• Manage and Update Audit and TQA Tracker / Databases.
• Compile Vendor Qualification forms post CAPA response approval.
• Management of Manufacturing licenses and GMP certificates of all Aspen Pharmacare vendors.

External / Internal Audits Management:

• Coordinate audits relating to document and information management
• Coordinate and provide support during external and customer and statutory external audits

Scheduling and Prioritising Post-Importation Testing (PIT) with the Labs

• Scheduling and prioritising with the labs for PIT.
• Track testing status of products at the labs and provide feedback to the relevant parties.
• Ensure all lab issues and delays are escalated to the relevant parties for investigation.

Samples Requests and Retention Management

• Request samples required for batch review and PIT testing from the relevant Aspen / Third Party warehouse.
• Request annual stability samples from Vendor, Aspen or Third-Party Warehouse
• Monitor progress of sample receipt and highlight any delays to the relevant warehouse personnel and QA team members.
• Keep track of the time taken to receive samples from the warehouses, highlight this to relevant teams and assist in finding solutions to ensure quicker turnaround time for sample receipt
• Ensure samples are correctly stored, easily retrievable, and available for review during release process.
• Ensure that relevant courier parcels are sent off timeously and to the correct address.
• Liaise with Courier Company on details of delivery.
• Address any delays in delivery of parcels with Courier Company.

Management of Lab set-up and Non-stock SAP Purchase Requisitions

• Initiate of non-stock purchase requisitions on the SAP system for Stability and Compliance trials, PIT, PITE etc.
• Ensure that the non-stock purchase requisitions are accurate and actioned timeously to prevent delays in QA processes.
• Provide the Buyers with the necessary information for creation of the non-stock purchase order.
• Order any Reference Standards and Columns, where required for Aspen products, for the PIT lab.
• Provide feedback on status of lab set-up and Launch meeting.
• Vendor Audit Invoices for cross charge or requisition creation.

Waste Management

• Ensure that there are written procedures describing the action to be taken for waste.
• Manage the coordination of product waste destruction, in consultation with PA Woodmead QSM for products/samples at Woodmead.
• Liaise with the necessary Third-Party Waste Destruction Service Provider/s relating to Waste Management requirements.
• Ensure that all responsible departments/divisions have necessary controls and documentation in place for product waste management.

Maintenance of Electronic QA Folders and Spreadsheets

• Save product information (e.g. COA) received in the relevant QA folders.
• Update the daily block list with regards to progress of the products in QA awaiting release.

Office Administration

• Ensure stationary are ordered as and when required
• Ordering and Managing of Office consumables including Fruits / Tea / Coffee / Toiletries etc

Continuous Improvement

• Identifying gaps within current processes and investigation and proposing ways to close the gaps
• Identifying ways to streamline processes, resulting in greater efficiency and productivity
• Ensuring the necessary information and statistics generated by the department is accurate and easily retrievable

Other

• Manage Projects assigned to you as per guidelines from the line manager and as per agreed timeframes
• Regularly provide feedback on progress of projects and highlight any issues that require manager’s attention
• Adherence to company HR Policies and Procedures
• Adherence to Company Health and Safety Policies and Procedures
• Participate in training programmes
• Any other duties as assigned by line manager / HOD

Requirements
EDUCATIONAL REQUIREMENTS

• Matric (Grade 12)

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• A minimum of 1-year administrative experience
• Experience in a Quality GxP-accredited pharmaceutical environment (preferably in an MA Holding entity, Distributor, Wholesaler, or manufacturing facility)
• Experience with electronic quality management systems (QMS)
• Sound knowledge of Good Manufacturing Practice and Good Documentation Practices.

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• High level of integrity, ethical values and confidentiality
• Good decision making
• Customer focus / service & outcome orientated
• Initiating action, follow up and time management
• Positive, diligent and hard worker (Can do attitude)
• Self-motivated and quality orientated
• Problem solving, attention to detail and analytical skill
• Planning, organizing and prioritization skills
• Able to work independently and within a team
• Initiative and information seeking
• Accuracy & Tenacity
• Flexibility and tolerance for ambiguity
• Capacity for resistance to stress
• Ability to multitask and strong proven follow-up skills is a requirement.
• Excellent communication skills, including verbal and written proficiency in the English language