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The Market Access Pricing And Projects Manager will evaluate strategic and operational pricing strategies and implement and track market access activities .
RESPONSIBILITIES:
Establishes internal relationships within the business to identify their key needs, KPI’s, uncertainties driving decision making and potential areas for strategic collaboration.
Establishes external Payer relationships to identify their key needs, KPI’s, uncertainties driving decision making and potential areas for strategic portfolio collaboration.
Leads the development and communication of Market Access strategies to increase revenue in existing and future payer partnerships.
Drives the evidence generation plans of the medical team by combining external stakeholder needs together with commercial need.
Develops tailored vaccines solutions leveraging resources and appropriate resources from payer partners and third parties when applicable.
Acts as the business’s single point of contact for product portfolio and represents all the products across business planning processes.
Actively generates payer insights and ensures the inclusion thereof in strategic planning processes.
Utilizes payer landscape insights and knowledge to help refine the go-to-market strategies and pricing development across product portfolio.
Assists the broader organization in developing pricing capability in payer partnerships in an Affordability Constraint market.
Provides leadership and subject matter expertise on the changing pricing dynamics and the needs of the payer customer. Proactively shares best practices and leverages synergies across Business Units.
Collaborates with the Head of Market Access to coach the local sales teams on strategic market access and solution-based selling that delivers economic value.
Ensures Market Access projects, ideas and requests are communicated and tracked internally.
Able to develop project plans and pilots to address current pricing pain points such as Affordability, Healthcare delivery efficiency, patient challenges, disease population management.

Provide high quality patient care.
Assist with continuous development of staff.
Identify hazards in the workplace and provide solutions.
Treat emergency injuries.
Develop programs to maintain health and safety.
Identify work-related risks.
Document all injuries and illnesses.
Advising/managing the covid-19 screening SOP.
Examining all patients presenting with covid-19 symptoms.
Referring patients where need be for further medical examination.
Clearing patients to return to work.
Advising business on best practice.
Reporting back to management.

The QA Pharmacist is responsible for implementing, maintaining and monitoring the QMS in line with SA GMP guidelines, PIC/S guidelines and requirements and other standards where applicable.
Implement, maintain and manage the QMS system.
Ensure that a training management system is in place.
Implement & manage an effective document management system (DMS) and ensure all Master documents are managed in an effective manner.
Qualify and Assess vendors by implementing vendor management procedures in line with quality requirements.
Implement and manage the self-inspection program. Manage & Co-ordinate external audits from customers, partners and Health Authorities together with the RP.
Ensure that quality risk assessments are performed to assess aspects of the QMS and supply chain.
Implement, monitor and trend CAPA's implementation and effectiveness.
Implement and manage changes via a change control system.
Ensure Technical Agreements are in place with all customers, suppliers and 3rd party contractors.
Manage the Non-conformance Process. Report on the status of the QMS in the monthly QSMR.
Ensure all documentation is completed OTIF. Support the Validation Process.
Oversee the Stability program and ensure it is implemented and managed.
Monitor the waste management program.
Assist in the Regulatory Affairs of new products, line extensions, major variations & lifecycle management.
Assist in the QA Batch release process, when required. Deputy Responsible Pharmacist: Perform all duties related to the role in the absence of the RP.
Manage the department within operational budget.
Perform duties as requested by line management and or executive committee.
Performing duties on time
Performing duties with minimal errors.
Reporting deviations/ non conformances to manager on time.
Ensuring all protocols are prepared sufficiently in advance.
Ensuring project plans are maintained.
Ensuring all processes comply to cGMP Principles.
Ensuring that all data complies for Good Documentation Practices.

Direct Reports: All production staff including packers, operators, supervisors, pharmacist assistants, and where applicable, all visitors to the facility must directly report to production pharmacist on duty in absence of the Production Manager.
Management and overseeing of the quality production pharmacists and staff members.
Ensures the general cleanliness and hygienic conditions of the manufacturing areas and production personnel.
Supervises duties of subordinates staff to ensure discipline and good working culture among the staff.
Liaising with warehouse to prepare components for new jobs timeously and assessing shortages before job is put on line.
Overseeing the dispensary with regard cGMP.
Overseeing the dispensing and weighing of materials.
Overseeing of all manufacturing activities, including opening, closing and clearance of production lines.
Ensuring production areas are tidy at all times and cGMP compliant.
Exercising strict control over Scheduled Substances and ensuring that the scheduled substances register is up to date.
Checking machines are clean after and before use and maintaining cleaning log files.
Working closely with Maintenance department in maintaining equipment, planning preventative maintenance and addressing ad-hoc breakdowns.
Liaising with maintenance technicians to do changeovers on machines timeously.
Reporting breakdowns to Maintenance Manager, Production Manager and Responsible Pharmacist.
Introducing new products within the facility and conducting trial and validation batches in conjunction with the Validation Department.
Overseeing of mixing and blending of powders and liquids.
Liaising with QA on all quality issues.
Update Standard Operating Procedures (SOP's) and ensure that the staff are trained on the updated versions.
Where applicable, perform quality risk assessments and conduct departmental risk assessments.
Create and update BMRs for new products and amend existing documents where applicable.
Investigating non-conformances and out of specifications (OOS) and compiling non-conformance reports (NCRs).
Attending to internal and external audit and responding with corrective actions and preventative actions (CAPAs).
Coordinating training of staff in GMP and GWP, together with the Responsible Pharmacist, QA Manager and Line Supervisors.
General responsibility in the absence of the Production manager and Responsible Pharmacist. This list is an indication of the work expected, but is not conclusive.
Must ensure efficient use of all utilities, consumables and packing materials in order to maximize yields and reduce rejects and wastages.
Must plan, authorize and manage overtime to ensure only necessary expenditure is made to meet production goals.

Management and overseeing of the quality production pharmacists and staff members.
Ensures the general cleanliness and hygienic conditions of the manufacturing areas and production personnel.
Supervises duties of subordinates staff to ensure discipline and good working culture among the staff.
Liaising with warehouse to prepare components for new jobs timeously and assessing shortages before job is put on line.
Overseeing the dispensary with regard cGMP.
Overseeing the dispensing and weighing of materials.
Overseeing of all manufacturing activities, including opening, closing and clearance of production lines.
Ensuring production areas are tidy at all times and cGMP compliant.
Exercising strict control over Scheduled Substances and ensuring that the scheduled substances register is up to date.
Checking machines are clean after and before use and maintaining cleaning log files.
Working closely with Maintenance department in maintaining equipment, planning preventative maintenance and addressing ad-hoc breakdowns.
Liaising with maintenance technicians to do changeovers on machines timeously.
Reporting breakdowns to Maintenance Manager, Production Manager and Responsible Pharmacist.
Introducing new products within the facility and conducting trial and validation batches in conjunction with the Validation Department.
Overseeing of mixing and blending of powders and liquids.
Liaising with QA on all quality issues.
Update Standard Operating Procedures (SOP's) and ensure that the staff are trained on the updated versions.
Where applicable, perform quality risk assessments and conduct departmental risk assessments.
Create and update BMRs for new products and amend existing documents where applicable.
Investigating non-conformances and out of specifications (OOS) and compiling non-conformance reports (NCRs).
Attending to internal and external audit and responding with corrective actions and preventative actions (CAPAs).
Coordinating training of staff in GMP and GWP, together with the Responsible Pharmacist, QA Manager and Line Supervisors.
General responsibility in the absence of the Production manager and Responsible Pharmacist.
This list is an indication of the work expected, but is not conclusive.
Perform other duties as and when requested, by Department head and manager within own area of abilities and responsibilities.
Direct Reports: All production staff including packers, operators, supervisors, pharmacist assistants, and where applicable, all visitors to the facility must directly report to production pharmacist on duty in absence of the Production Manager.

Responsible for maintaining validation and calibration schedules while liaising with contractors.
Prepare CSV documentation to meet 21 CFR Part 11, ISPE, etc Plans, Protocols and Repots.
To ensure assigned validation exercises are conducted in a timely manner and in compliance with GMP and project milestones.
Participate in change control assessments and project meetings to ensure the compliant status of affected equipment is not compromised.
Participate in corporate, regulatory and internal audits. Focus on process, cleaning and product validation studies and maintain GMP compliance at all times.
Managing of site validation documentation and completion for validation risk assessments. Preparation and Review of Departmental SOP's.
Work with QA, Production, Maintenance and other departments to resolve audit findings.
Perform ad hoc duties as and when requested by Line management and Executive Committee.

Non-Negotiable Responsible for Regulatory Affairs functions across the board Experience gained in liaising directly with Health Authorities with regards to clinical trial applications, new marketing authorization applications and lifecycle maintenance - examples to be provided. Expertise regarding pharmacovigilance, quality systems in pharmaceutical industry or Biotechnology sector Create and cultivate alignment on new regulatory pathways for current and new product development in South Africa Provide support and run regulatory affairs contribution to the product launch activities when and as needed.
Create, advise and approve local registration strategies based on regulatory requirements, product knowledge and the company strategy Pre-emptive in identifying emerging issues that might impact product development Responsible to obtain and maintain regulatory licenses Review, maintain, update, compile and submit dossiers for current and new products in South Africa Ensure guidelines and regulations compliance is adhered Ensure to update and advise department and stakeholders on regulatory matters.

Carries the Ethical and Legal Responsibilities for the Regulatory, pharmaceutical and Technical aspects of the company.
Represents the company in dealings with the Registration and Pharmaceutical authorities and ensures compliance with applicable legislation.
Quality assurance and Improvement throughout all processes.
Ensure that all products manufactured and released comply to the requirements of the Medicines Act and Pharmacy Act as described above.
GMP Compliance by Pre-Pack Unit, GWP Compliance from Receiving, Warehouse, Stock Control, Checking, Invoicing, Dispatch and Distribution.
MCC, SAPC, Compliance throughout the Depot.
Quality Control throughout the Depot process from Procurement, Receiving, Warehouse, Stock Control, Checking, Invoicing, Dispatch, Pre-Pack.
Business Process Perspective:
Manage the business as per SAPC Responsible Pharmacist requirements stipulated in the Pharmacy Act (Act 53 of 1974), and the Medicines and Related Substances control Act (Act 101 of 1965).
Ensure South African Pharmacy Council (SAPC) accreditation is in place. Responsible for development and management of equipment validation and calibration plan.
A responsible pharmacist must ensure prior to releasing a batch of any medicine for distribution from the pre-packing unit, that the following obligations have been complied with:
The principles of GMP have been followed;
The principals of processes have been validated;
All the necessary quality control checks have been performed, and account taken of the re-packing and packaging conditions including a review of batch records.
Any changes or deviations in , packaging or quality control have been notified in accordance with a well-defined reporting system before any product batch is released.

Provide high quality patient care.
Assist with continuous development of staff.
Identify hazards in the workplace and provide solutions.
Treat emergency injuries.
Develop programs to maintain health and safety.
Identify work-related risks.
Document all injuries and illnesses.

The Key Performance Areas for this position include:
Core Technical:
Fully accountable for 3 core pillars:
Company wide Project Management.
Company wide Business architecture.
Operational Excellence and Visual Performance Management.

Primary Responsibilities:

Managing the Project Management Office and provide support to individual project managers.
Identification, scoping and execution of the business architecture for company-wide operational systems Establish and Manage the operational excellence function.
Establish, prioritise and manage the continuous improvement program. Establish and manage a visual business performance management system (VPM) for industrial operations Custodian of the change management process for all major projects and business systems.
Custodian of the Project Management methodology and standards.
Ensuring resource allocation is driven by the relative project priorities.
Provide strategic support to ensure inter-departmental synergies and behaviour within a comprehensive programme management governance framework.
Implementing and managing changes and interventions to ensure project goals are achieved.
Provide input, training and guidance in the establishment of Pre-Project proposals.
Budget for Pre-Project Work for Large Projects or Programmes.
Evaluate and alert on operational risk across Biovac site and advise on mitigation interventions (timeframes and responsibilities).
Present progress of tactical versus strategic plan including operational risk to Management and Executive on a weekly and monthly basis.
Review planning to provide executive with assurance on achievement of tactical plan.

People Management (Inter and intra departmental):
Align departmental focus areas and outputs to the business’s objectives.
Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.
Negotiating with operational heads for required resources once a project has been approved.
Procure contingency resource(s) as and when required for large infrastructure or specific technical projects.
Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
Role profiling, goal setting and performance management of Project managers and staff within the department.
Develop and implement a knowledge management infrastructure within the department to ensure Intellectual Property is effectively maintained.
Growth, succession & retention of departmental talent.
Accountability for own and team’s personal and professional learning & development to ensure technical and leadership bench strength within the department.
Identify key opportunities and deliverables as required by departments for cross functional synergies/ project work.
Identify bottlenecks across departments to solve capacity/ quality concerns.
Upon demand, technically advise and support staff members representing the PMO on project management standards and methodology including documentation and records.
Provide technical support and guidance to other departments on managing smaller projects Identify key people on site as targets for retention.
Business Management:

Shared accountability for achieving the site’s operational and tactical plans and mitigation of any risk to the site operation including workflow, ethics, quality, finances, regulatory compliance and other material company requirements.
Identify and continuously present key opportunities and synergies that will improve and/ or expand the operation within own and/ or other departments.
Lead or participate in departmental and/ or site wide projects.
Monitoring & reporting on key operations, critical numbers and key performance indicators that impacts the business’s short, medium and long term objectives.
Participate with the site management team in proactively mitigating risks and find solutions where possible.
Lead organizations transition into commercial operations and mind-set as well as instituting this across site with regards to managing efficiencies, reducing wastage and contributing to overall profitability.
Responsible to develop and maintain a 3-year rolling plan to effectively operationalise the company strategy as defined by Biovac’s board and executive team.

Quality Management:

Building own, team and site’s GMP Knowledge and Compliance.
Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
Establish and maintain a state of control related to quality management within the depa