Ignatius Venter

• Maintaining the Basic Pharma Manufacturing Quality Management System in alignment.
• Ensuring alignment of the Basic Pharma Manufacturing Quality Management System to guidelines set within Eudralex EU Guide to Good Manufacturing Practice and its related annexures.
• Mentoring, assisting and leading department team members, helping them achieve departmental targets.
• Maintaining the Basic Pharma documentation management systems including SOP, WI, batch record documentation, protocols among others including roles incorporating author, reviewer and approver.
• Creating, compilation and evaluating quality metrics.
• Interacting on quality items (including deviations, change controls, CAPA's, product complaints etc) with internal stakeholders within BPM to achieve the desired quality objectives to ensure safe, effective and high quality medicines.
• Interacting with external stakeholders on inspections, queries and other quality queries.
• Performing self inspections and maintaining the self inspection programme.
• Facilitate external regulatory inspections (IGJ, BSI) and other third party customer audits. Collaborating on action plan and authoring CAPA response.
• Implementation of problem solving techniques and work experience in challenging deviations and/or CAPA's. Further supporting with authoring, review and approving quality items.
• Maintaining the Basic Pharma Approved Suppliers list through the introduction, qualification and maintenance of suppliers.
• Performing audits of Basic Pharma Suppliers.
• Performing trending evaluations on quality system items such as deviations and product complaints.
• Period added responsibility for overseeing the Basic Pharma Stability programme (2023-2024).
• Compiling and maintaining the Basic Pharma Contamination Control Strategy and evaluation of Annex 1 gap assessment.
• Assisting, guiding and investigating viable and non-viable investigations within cleanroom facilities.
• Compiling environmental monitoring trends within the cleanroom facilities.
• Enhanced team productivity by implementing efficient work processes and regularly reviewing performance metrics.
• Assisting with the Basic Pharma Manufacturing training programme.
• Assisting with compiling, reviewing and approving qualification documentation.

Key responsibilities:

Responsible for the sterility assurance of all products manufactured on site.

• Ensures compliance in accordance with Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974, and organization’s policies, procedures, and other applicable laws.
• Continuously build and support sound quality assurance culture aligned to cGMP within Biovac.
• Identify and continuously present key opportunities and synergies that will improve and/ or expand operation within own and/ or other sections.
• Lead or participate in department and/ or site wide projects.
• Participate with department manager and other senior and middle managers in proactively mitigating risks and find solutions where possible.
• Support Departmental Manager on conducting effective and comprehensive costing, budgeting and expense management for QAO department, taking all overlapping site activities into consideration.
• Provide technical support to Biovac to ensure smooth transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage, and contributing to overall profitability.
• Define, implement, and own a holistic contamination control strategy for site.
• Evaluate, improve, and own a holistic environmental monitoring programme for site (including utilities monitoring).
• Scope and lead Sterility Assurance Group review process (weekly, monthly, annually).
• Provide direct input and support as SME for all major events/excursions which may impact the sterility assurance of product or process (Deviations, CAPAs or change controls) on site
• Physically leads root cause analysis pertaining to sterility assurance investigations for example by means of Gemba walks into various cleanroom or actual observations of activities.
• Lead and execute relevant sterility assurance risk assessments for both site processes and/or external suppliers
• Continuously evaluate, amend and lead required aseptic process simulations in order to meet international best practices
• Review and supply guidance on best practices for aseptic manufacturing or sterilisation processes within operations
• Assists with creation and updating of SOP’s and Work Instructions on continuous basis and ensure the manufacturing and production activities comply with Standard Operating Procedures.
• Assists with creation and updating of batch records on continuous basis and ensure manufacturing and production activities comply with Standard Operating Procedures.

Key responsibilities:

• Deputy Responsible Pharmacist of Aspen SVP (Pty) ltd
• Management of quality team with Aspen SVP Quality Assurance.
• Assist in coordination of batch documentation review and release on time and in full.
• Conduct pharmaceutical and/or contractual approval, quarantine, or rejection of batches in compliance with marketing authorisation.
• Monitor VMP plan and review and authorise validation documentation.
• Process validation report review and approval.
• Conducting internal audits across various departments.
• Participating and leading company representation during external regulatory and customer audits including European, Australian and American Regulators.
• Ensure Annual Product Quality Reviews are performed.
• Initiate and maintain relationships with third party customers and external authorities.
• Write quality reports and follow up on corrective actions.
• Approve and/or reject starting materials, components and finished product.
• Communication with site management team
• Monitor Key Performance Indicators on daily, weekly and monthly basis.
• Manage departmental financial, SHE and HR responsibilities and activities.
• Achievements:
• FDA, TGA, LAsD and SAHPRA audit experience obtained.
• Assisted in achieving Aquarius product validation completion.
  

Responsibilities:

• Coordination of the daily compliance audit team activities within Aspen SVP.
• Coordination of the QA Vendor Coordinator activities at the sterile packaging supplier located in Durban.
• Ensure adherence to internal standard operating procedures and policies through monitoring and review.
• Implementation, review and assurance of good aseptic behaviour in clean room individuals.
• Conducting investigations and root cause analysis of non-conformances by utilising problem solving techniques.
• Involved and coordinating both microbiological and chemical excursion investigations.
• Preparation of the facility for external regulatory or customer audits.
• Conducting and coordinating internal audits. Assist in the resolution of these audits.
• Conducting external audits of packaging suppliers including sterile component suppliers.
• Conducting and participating in risk assessments.
• Assist in completion of quality system elements such as deviations, change controls and CAPA's.
• Retention sample management.
• Assist and coordinate in both ad hoc and visual inspection AQL inspections.
• Compiling and final release approval of facility SOP's
• Human resource management including performance reviews.
• Achievements:
• Management skills obtained due to the managment of a wide array of individuals.
• Learning and implementation of quality principles.
• Investigation and problem solving techniques.
• Informal training approach to assist in on-the-job excursions
• Enhanced regulatory knowledge.

Responsibilities:

• Review batch documentation and production conditions to assess compliance to quality procedures, standards and product specifications.
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programmes, product specifications and GMP guidelines.
• Approve and release production batches.
• Ensure batch release priorities aligned with customer expectations and OTIF principles.
• Experienced gained with Bill of Materials and Item Master management.
• Experienced in update of batch manufacturing and packaging records.

Achievements:

• Utilised background as production pharmacist to act as strong foundation for Quality Assurance.

Responsibilities:

• Primary custodian of GMP on production floor.
• Line clearance and line opening processes.
• In process quality checks undertaken as part of responsibilities.
• Preparation and production audit of batch packaging records to be sent to DCO.
• Production management of quality related items such as SOP updates, deviation, change control and CAPA's.
• Handling of scheduled material.

Achievements:

• Act as tutor for incoming pharmacists.
• Develop training module for production preparation and auditing of batch packaging records.
• Drove project to update all Packaging Bill of materials for all products within Unit 3 Packing lines
• Create batch packaging record for all items packed on Unit 3 packing line from old packaging directive to Unit 1 Batch Packaging Record template.
• Project to merge SOP to reduce number of procedures.

Community service pharmacist to provide clinical and hospital pharmaceutical activities to the Ceres Community health centre and the surrounding clinics.