Quality Assurance Pharmacist - Vendor Management (JHB North) at Aspen Pharma Group

OBJECTIVE OF ROLE

• The role undertakes responsibility for the pharmaceutical tasks within the Vendor Management division of the Quality department for Pharmacare Limited, ensuring Vendor and Company compliance with sound 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.

KEY RESPONSIBILITIES

General Operational Activities

• Execute daily tasks and work instructions according to the relevant SOPs.
• Adherence 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.
• 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
• Active collaboration with the regional and global quality, regulatory and operational teams to ensure the appropriate flow of information and decisions, to seek advice, inputs, guidance and work on any regional or cross functional projects
• Perform any other administrative tasks relating to your work as and when required
• Effective management and utilization of resources to keep processes cost effective

Customer Service

• Manage the Quality relationship between Aspen and Third-Party Contract manufacturers, Licensors, Testing Laboratories, Distributors, Wholesalers and other Regulatory and Quality service providers, providing guidance on Quality and GxP matters and decisions.
• Manage the Co-marketing arrangements with distributors, e.g. GSK, Amgen, Lilly and other third-party products where Aspen is the appointed agent to market and distribute
• Involvement with technical customer queries and product investigations
• Responding to enquiries in a timely manner, giving advice on quality requirements
• 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
• Provide quality support for the SA and SADC Commercial, Supply Chain and Value Chain structures, as it relates to Vendor Management, Distribution and Wholesale matters

Management of GxP Vendor Audits

• Manage vendor audit schedules.
• Conduct vendor audits.
• Compile audit reports.
• Document audits on the electronic QMS
• Ensure that appropriate CAPAs from audit findings are tracked and followed through to completion.
• Perform desktop audits, when required as per SOP.
• Ensure risk assessment of all vendors is conducted, and audits are planning according to this risk categorization.
• Periodically request information from vendors regarding recent regulatory inspections of their company, review this information and determine risk (if any) to the service provided to Aspen and its product.
• Ensuring vendor ratings system is utilized to assess vendor compliance.

Management of Technical Agreements, Manufacturing Licences and GxP Certificates

• Ensure that technical agreements and SLAs are in place for all third-party vendors involved in manufacture, packing, testing, storage and distribution of finished products
• Draw up Technical and Service Level Agreements (SLA’s) with new vendors/ affiliates / Distributors (SA & SADC) to ensure that all GxP roles, responsibilities and requirements for all parties are stipulated, and both agree to comply
• Ensure that active agreements are being reviewed and updated according to their review dates
• Perform gap analysis to determine which vendors do not have an agreement in place and formulate and actionable plan to close the gap.
• Compile and maintain a database of all vendors for Pharmacare Ltd. containing all relevant information to assist in audits and Technical Agreement (TA) / SLA management.
• Ensure that the TA and SLA SOP, templates, and associated documents are current and effective on the electronic QMS and are reviewed when required.
• Compile TA declaration for the RA department for new submissions and amendments.
• Management of Manufacturing licenses and GxP certificates of all Aspen Pharmacare vendors.

Distribution and Wholesale Quality

• Provide Quality support for Commercial, Distribution and Logistics structures as relates to Distribution and Wholesale
• Ensure Distributor and Wholesaler compliance with sound Quality Assurance principles, GxP and regulatory requirements relating to the warehousing /distribution of medicines in South Africa and SADC
• Ensure appropriate management of blocked stock notifications, Co-Marketing arrangements with distributors, Material listing verifications, Change management, Permit application process and Post-release incidents at internal and third-party distributors / wholesalers

Quality Management Systems and GxP Compliance

• Ensuring that Pharmacare and its vendors comply with current and future GxP standards and requirements
• Observing and complying with GxP requirements (e.g. GMP, GWP, GDP, GLP, GDP, etc) as outlined by guidelines, the company SOP’s and written instructions in all tasks and activities
• Observing and complying with Policies, SOPs and processes
• 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
• Compile, review and update SOPs and related documentation (e.g. Work Instruction, standard forms, trackers and all relevant Quality 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 to align accordingly
• Maintain Templates and Lists
• Change Ownership for all assigned change controls and completion of Action Items
• Deviation and CAPA management
• Risk Management, mitigation and performing Quality Risk Assessments where required
• Ensure ongoing Quality and QMS requirements and commitments, as per latest SAHPRA PICS and other relevant guidance, is fulfilled and maintained
• Provide vendor management information for QSMR and any other reporting requirements
• Participating in QMS monthly and annual reviews
• Conducting / assisting with internal self-inspection audits
• Complete Change controls, Change actions, Deviations, CAPA, Effectiveness checks, Audit Finding records in accordance with the requirements of the QMS Due dates

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
• Enduring the necessary information and statistics generated by the department is accurate and easily retrievable

Other

• ITAC Permit management
• PIT Exemptions
• Assisting with Batch Release process, including deviation management where required
• Participating in Regulatory and Third-Party inspections and audits of Pharmacare or its contracted parties
• Adherence to company HR Policies and Procedures
• Adherence to Company Health and Safety Policies and Procedures
• Participate in training programmes
• Keep abreast of developments in best practice, inspection trends and all QMS related activities

Requirements
EDUCATIONAL REQUIREMENTS

• Matric
• Bachelor of Pharmacy Degree or equivalent (Registration with the South African Pharmacy Council as a practicing Pharmacist)
• Technical qualification related to the pharmaceutical industry is advantageous.

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• Minimum of 3 years’ experience in a GxP-accredited pharmaceutical environment, preferably in an MA Holding entity, Distributor Wholesaler or manufacturing facility, of which at least one year must be in Quality
• Quality Auditing experience is mandatory
• Experience in medicine legislation and related guidelines and codes of practice
• Experience in Quality Management Systems required
• Experience in Vendor Management within a GxP-accredited pharmaceutical environment
• Advanced knowledge of the legislation applicable to the pharmaceutical industry in South Africa (including but not limited to the Medicines and Related Substances Act 101 of 1965, as amended)
• Advanced knowledge of SAHPRA requirements and guidelines
• Sound knowledge of the pharmaceutical industry
• Advanced knowledge of Pic/s and EU Guidelines

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• Excellent communication skills, including verbal and written proficiency in the English & Afrikaans languages
• Administrative, planning and organizational skills
• Electronic database management skills
• Report writing skills
• High level of integrity, ethical values and confidentiality
• Ability to make good decisions
• Customer focus / service-orientated and outcome based
• Initiating action, follow up and time management
• Positive, diligent and hard working
• Ability to prioritize and co-ordinate work
• Self-motivated
• Quality orientation
• Stress tolerance and conflict resolution
• Problem solving, attention to detail and analytical skill
• Methodical implementation skills
• Negotiation Skills