Release Pharmacist at The Biovac Institute

Job description

• Align section focus areas and outputs to the business’s objectives.
• Conduct section planning and execute activities within own scope of accountability.
• Adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.
• Role profiling, goal setting and performance management of supervisors and staff within the section.
• Implement a knowledge management infrastructure within the section to ensure intellectual property is effectively maintained.
• Growth, succession & retention of talent pools within the section.
• Accountability for own and team's personal and professional learning & development to ensure technical and leadership bench strength within the section.
• Ensure accurate and documented delegation of ongoing operational activities in the event of key staff members’ absence in line with the related policies and SOP’s.
• Conduct effective employee relations in accordance with labour legislation, company policies and procedures and address any performance and conduct concerns and risks timeously.
• Ensure that Occupational and other risks related to roles within the section are defined and mitigated.

Technical Competencies required to perform this aspect of the role:

• KPI Development
• Resource & Capacity Planning & Management
• South African Labour Legislation
• Coaching & Mentoring of peers & staff
• Shared accountability for achieving the site’s 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 sections.
• Lead or participate in section and/ or site wide projects.
• Monitoring & reporting on key operations, critical numbers and key performance indicators that impact the section’s short, medium and long term objectives.
• Participate with the department manager and other senior and middle managers in proactively mitigating risks and find solutions where possible.
• Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.
• Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.
• Develop and maintain 18 month rolling plan for own section.

Technical Competencies required to perform this aspect of the role:

• Processes Development and Review
• Intermediate proficiency in Microsoft Word, Excel, Power point and Project.
• Metric & KPI development
• Technical Report Writing
• Operational Costing & Budgeting
• Statistical Literacy
• Coaching & Mentoring of peers & staff

Release pharmacist function

• Ensure development, implementation and continuous review on performance of the pharmaceutical quality management systems (PQS) to ensure its continuing suitability and effectiveness
• Facilitate Regular Review of Product, Process and PQS performance and coordinate Management Review (Process, Product and Pharmaceutical Quality System PQS performance).
• Coordinate specified elements of the Pharmaceutical Quality System
• Ensure planning of activities within the Pharmaceutical Quality by providing central coordination of required plans
• Implementation and operational management of specified QA processes: Deviations, CAPAs, Change Control, Quality Risk Assessment, including process mapping and proactive definition of Critical Process Parameters
• Ensure the participation and coordination of stakeholders in Deviations, Change controls, and CAPAs.
• Promote the understanding of product and processes and their variability
• Define and manage the implementation of Quality metrics and their tracking.
• Ensure that the Quality Council is in place and effective and ensure that the outcome of the monthly meeting is in a report
• Participate in quality oversight forums as required: e.g. Quality Steercom
• Benchmark internal practice against quality standards of industry and regulatory bodies and create awareness of GMP updates
• Review, approve /reject and control GMP Documentation and Records to ensure compliance to the requirements of the business, GMPs and regulatory agencies including SOPs, WI, Batch records; PPM ref file and reference samples.
• Participate in risk assessments conducted and where appropriate risks mitigated
• Manage Product Quality Complaints and participate in the investigation of quality related complaints where needed.
• Manage and coordinate 3rd party and regulator audits, and ensure tracking of regulatory commitments.’
• Perform internal and supplier audits as agreed with QA Operations
• Research and provide expert input as requested, e.g. gap analyses, investigations

Manages the Quality Standards with regards to:

• Product sampling for re-testing
• Batch documentation auditing record and control
• Finished product release
• Quality of products out in the market
• Storage and control of retention samples
• Submission of status report
• QA Artwork/packaging approvals
• Development control and approval of new product bar codes
• Review and approve master documentation
• Reviews and Approves Stability test results
• In order to comply with MCC and PIC guidelines.
• Review monitoring of temperature on incoming shipments (deviations)
• Evaluation and monitoring of stock control system to control authorised product release and automatic quarantine and release of stock
• Contribute GMP, technical and system knowledge, experience and learning to QA investigations and evaluations
• Leads cross functional activities related to quality systems and represents quality systems on project teams
• Mentor junior QA release pharmacist(s)

Technical Competencies required to perform this aspect of the role:

• Excellent understanding and working knowledge of Quality Operations and systems.
• Detailed knowledge of pharmaceutical industry standards and guidelines in GMP, Quality and Laboratory Management
• Pharmacopoeia methods, standards, guidelines and relevant agency recommendations on QC testing.
• Documentation Management
• Inventory Management
• Environmental, Health & Safety Management
• Statistical Trending & Data Analysis
• Metric Development & Report Writing
• Coaching & Mentoring of peers & staff
• Review & Auditing Skills
• Quality Management
• Building own and team’s cGMP Knowledge and Compliance.
• Assist in driving Quality Culture, Quality Objectives and Quality Risk Management.
• Establishing and maintaining a state of control within section.
• Driving Innovation and Continuous Improvement within the section.
• Ensuring that Section is audit ready; closing audit findings.
• Ensure effective management of Deviations, Change Controls, CAPAs within the section.
• Establish escalation processes to raise quality issues to the appropriate levels of management.
• Advocate continual improvement within the section.
• Ensure a state of accuracy across all documentation within own span of control in support of achieving optimal quality across Biovac.
• Ensure that the 4 eye principle is maintained when reviewing documentation.
• cGMP vaccine manufacturing- quality and regulatory compliance & best practice knowledge e.g. PIC/S, MCC requirements,
• Total Quality Management & Quality Management Systems
• Technical trending & report writing
• Coaching & Mentoring of peers & staff
• Generic Competencies required to perform this role:
• Planning, Organising, Execution & Delegation
• Strategic & Holistic Thinking
• Creative Problem Solving & Innovation Skills
• Sustainable Stakeholder Management
• Financial Acumen
• Commercial Awareness
• Action & Results Oriented
• Assertive & Resilient
• Adaptable in Responding to change
• Negotiation and influencing skills
• Proactive in mitigating risk
• Clear, timely and effective communication skills both verbally and in writing
• Analytical Ability

Qualifications and Skills Required:

• Degree in pharmacy
• Preferred: Post Graduate
• Recognition is given to Prior Learning and practical experience.
• At least 6 years’ experience in pharmaceutical/ biotech manufacturing industry.
• At least 2 years’ experience at junior to middle management level.
• Experience in quality management systems within a cGMP facility.
• Experience in aseptic (sterile) manufacturing
• Experience in having faced successful local and/ or international regulatory audits.
• Experience in general business management within a commercial environment
• Knowledge of Pharmaceutical Manufacturing related legislation