Quality Lead: Quality Assurance (Port Elizabeth) at Aspen Pharma Group

OBJECTIVE OF ROLE

• The role undertakes responsibility for the oversight and management of the Pharmaceutical Tasks within the Quality Assurance division of the Quality department for Pharmacare Limited for all products marketed and distributed by Pharmacare (Pharmacare Ltd and Third-Party Partners), as delegated by the Responsible Pharmacist,  ensuring compliance with sound QA principles, SOPs, 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 related 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.
• The role responsibility includes management of the Batch Release process for externally supplied products for Pharmacare Limited and Third-Party products, and management of the Stability and Vendor Management process for all Pharmacare Limited Products.

KEY RESPONSIBILITIES

 General Operational Activities:

• Adhere to agreed Key Performance Indicators (KPI)
• Support the continuous development and improvement of the Quality function while upholding Aspen core values
• 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
• Manage active collaboration and co-ordination with internal and external business units, including the local Regulatory, Commercial and Operations teams to ensure the appropriate flow of information and decisions
• Effective management and utilization of resources to keep processes cost effective.
• Budget planning and management
• Collating data for ad hoc requests
• Ensure compliance with GxP for Manufacture, Testing, Storage, Distribution as well as compliance with applicable local regulations.
• Provide systems and SOPs implementation support for identified Pharmacare Departments/Divisions.
• Oversee all Applicant quality assurance activities as delegated by the Responsible Pharmacist.
• Keep abreast of developments in best practice, inspection trends and all QA related activities and maintain a high and up-to-date level of QMS, QA, auditing, and therapy area of knowledge by attending conferences, training courses, reading relevant medical and scientific literature.
• Support with establishing professional working relationships with SAHPRA and other Regulatory Authorities
• Positive customer engagement
• Any other duties as assigned by line manager / HOD 

Quality Assurance

Batch Release

• Responsibility for the Batch Release process (Outsource/CMO and Third-Party Partners), including Post-Importation Testing and related deviation and CAPA Management, in accordance with GxP requirements, Master documents and the registered product dossier
• Ensure that the Pharmacare Ltd-Woodmead Responsible Pharmacist has oversight of all batches released to market
• Ensure that all required steps are followed in the batch release process as per the SOP
• Ensure appropriate management of post-importation testing laboratories and associated reference standard management
• Ensure that any incidents that may impact product quality, safety or efficacy are escalated to the RA Manager: Quality and the Responsible Pharmacist for final decision and any regulatory action
• Ensure that a system is in place for QA evaluation and reporting of all product/batch related deviations to determine impact and recommended CAPA as well as effectiveness thereof.
• Ensure imported batches are tested within the agreed timeframe
• Ensure batches are released within agreed timeframe
• Management of blocked stock at the warehouses on a continuous basis
• Management of product reworks per SOP and GxP
• Management of Analytical method validation of Finished Product
• Management of Equipment Validation (OQ & PQ) and process validation including periodic validation

Investigating and Resolving QA queries

• Ensure that feedback and/or reports on QA queries are conducted and requested from Outsourced GxP partner (CMO, Lab etc) and are discussed with QA management.
• Ensure appropriate follow-up, logging, review and approval / rejection of all deviations (including Laboratory OOS), reports, etc
• Ensure appropriate handling and investigation of Suspect Stock Notifications to prevent recurrence
• Management of Raw Materials at CM as per SOP and assisting in resolving any queries on RM’s
• Ensuring SAP system is kept updated with regards to expiry date of stock, where applicable

Temperature Excursions

• Ensure all forms of temperature excursions (pre- and post-release) are investigated and CAPA’s implemented
• Make decision on appropriate action and where required escalate to the RA Manager: Quality and the Responsible Pharmacist for final decision and any regulatory action
• Temperature Excursions to be trended and appropriate actions taken to prevent recurrence 

Product Stability Management

• Ensure that all marketed products are placed onto a stability programme as defined by a stability protocol
• Ensure there is a process in place to monitor stability data as it becomes available and to ensure that the product meets its registered stability specification at the specified storage conditions, in the specified container for the duration of the approved shelf
• Decide on appropriate course of action to be followed in the case of a stability alert and ensure escalation to management and Responsible Pharmacist, to agree on course of action
• Ensure stability commitments and special stability trials are actioned within the required timeframe

Control of Highly Schedule Substances

• Ensure effective management and control of Highly scheduled products (S5 and above), according to relevant legislation and guidelines
• This includes requisitions, samples, registers, storage, permit management, reconciliations and submissions etc
• Ensure that any new products to be launched that will require a permit are setup with SAHPRA
• Conducting regular meetings with the logistics department to ensure that all S5 and S6 medicines coming into SA have the required permits
• Ensure Annual Returns are completed and submitted annually to SAHPRA before due date, end February.

QA Activities for NPL and Realignments

• Management of the QA activities for all New Product launches and realignments, ensuring that all activities are completed timeously so as not to delay launch
• PIT lab identification and setup (reference standards, columns and other materials), Analytical Method Transfer, etc
• SAP (SA Com and MPP) Item Master setup (QA)
• Master and executed document request/review per SOP
• Ensure review of the full batch documentation for the 1st two batches of a new product launch or realignment for compliance to GMP and product dossier

Vendor Management:

Vendor Management

• Maintain a database of all vendors and service providers for Pharmacare Ltd, including Vendor status
• Ensure initiation, review, maintenance and control of Quality, analytical and service level agreements for parties contracted to Pharmacare Ltd MAH
• Ensure Quality agreements are in place for all GxP third-party vendors involved in manufacture, packing, testing, storage and distribution of finished products and that requirements as specified in the Agreement are adhered to at all times
• Ensure that active agreements are being reviewed and updated according to review dates
• Manage vendor audit schedules
• Manage / conduct GxP vendor/supplier audits (including desktop audits)
• Ensure reports are compiled, completed per SOP and that appropriate CAPAs in place and are tracked to completion
• Ensure risk assessment of all vendors is conducted as per SOP and audits planned according to this risk categorization
• Establish KPIs for vendors, with vendor rating system, scoring and assessment completed at minimum twice a year.
• Ensure Vendor Risk assessments and completed and closed within due date.
• Escalate critical audit findings to RA Manager: Quality and Responsible Pharmacist.
• Ensure that all licences, GxP certificates, Regulatory audit reports and other related regulatory and GxP information from third-party vendors remains up to date / current

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 Quality Agreements are in place with all Distributors, including SADC region.
• Ensure appropriate management of Short-dated stock release process, Blocked stock notifications, Co-Marketing arrangements with distributors, Material listing verifications, Change management, Permit application process and post-release incidents (deviations, excursions) 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, policies, 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
• 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
• Ensure staff are trained on all SOP’s
• Ensure Staff complete Annual refresher GMP and SHE Training
• Maintain Templates and Lists
• Deviation and CAPA management
• Effectiveness Check management
• Audit Finding 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
• Completion of the sections in the QSMR relevant to QA
• 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

Other:

• PIT ExemptionsPermit managementITAC Permit ManagementWaste ManagementShort-Dated stock release processSupport with data for Dossier renewalsSupport the RA Manager: Quality in any strategic business projectsProblem solving for complex QA mattersContinuous improvementIdentifying gaps within the current process and investigate 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.Participating in Regulatory and Third-Party inspections and audits of Pharmacare or its contracted partiesParticipating in training programmesStationary and Consumable management, ensuring within budget
• Team Management:
• Promote diversity, equal opportunity and fair treatment in the workplaceCreate ways of doing things differently and more effectively within the departmentChallenge current ways of working with a view to suggesting more effective and efficient processes.
• Accomplish staff deliverables by communicating job expectations; planning, monitoring, and appraising job outputs; coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standardsPromote Aspen ValuesFoster collaboration and support within the Regulatory division and within the Pharmacare (SA Commercial) organizationEnsure adherence to company HR Policies and ProceduresEnsure adherence to Company Health and Safety Policies and Procedures

Requirements
EDUCATIONAL REQUIREMENTS

• Matric
• Bachelor of Pharmacy (or equivalent)
• Registration with the South African Pharmacy Council as a practicing Pharmacist

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• 7 years in the Pharmaceutical Industry (Manufacturing / Applicant) of which at least 5 must be in

Quality

• 4+ years’ Management experience
• Experience in the design, implementation and management of Quality Management Systems
• Experience in Quality Assurance
• Experience in Validation – Equipment, HVAC, Product, Process
• Experience in Vendor Management and Audits

SOFT SKILLS AND COMPETENCY REQUIREMENTS

• Innovative Thinking
• Interrogating Information
• Offering Insights
• Managing Performance
• Networking
• Planning and Organizing