Simoné Smit

SAPC-registered pharmacist with over 12 years of professional experience, including 8 years as Responsible Pharmacist at a licensed third-party complementary medicines manufacturer.

Experienced in pharmaceutical Quality Assurance, Quality Management Systems (QMS), GMP/GDP compliance, regulatory affairs, New Product Development (NPD), manufacturing oversight and batch certification and release.

Skilled in developing and reviewing Master Batch Manufacturing and Packaging Documents, SOPs, regulatory dossiers and client-specific technical documentation.

Extensive experience in customer complaint investigations, non-conformance reporting (NCR), deviation management, root cause analysis, CAPA, retention sample evaluation, batch record review, quality risk assessments and GMP auditing.

Experienced in formulation development, technical calculations, pilot batches, manufacturing scale-up, product documentation and regulatory compliance support.

Currently offering independent pharmaceutical consulting, quality assurance, technical documentation, regulatory support and locum pharmacy services. Open to remote, hybrid, contract and consulting opportunities.

Responsible Pharmacist / Quality Assurance Pharmacist at Parceval (Pty) Ltd (2018-08 – 2026-08)

Third-party manufacturer of complementary medicines and related health products. Responsibilities spanned pharmaceutical oversight, Quality Assurance, Quality Control, Regulatory Compliance and Technical Product Support etc.

• Oversaw Manufacturing, Packaging, Warehousing, Quality Control and product-release activities against applicable legislation, GMP, GPP and licence conditions.
• Certified and released batches (not directly to the market) following review of Manufacturing, Packaging, Quality Control and deviation records against approved specifications.
• Managed and improved the Quality Management System, including SOPs, master documents, quality records, document control and management-review inputs.
• Prepared, reviewed and controlled Batch Manufacturing and Batch Packaging Documents, verifying quantities, instructions, in-process controls and traceability.
• Investigated deviations, non-conformances, OOS/OOT results and complaints; managed root-cause analysis, CAPAs, effectiveness checks and change controls.
• Conducted quality risk assessments, maintained recall readiness and reviewed Product Quality Review data to identify recurring issues and improvement priorities.
• Prepared for regulatory and client inspections; coordinated evidence packs, responses and corrective actions, and supported licence maintenance and amendments.
• Conducted internal audits, qualified suppliers and service providers, reviewed technical quality agreements, and delivered GMP, GDP and SOP training.
• Researched dosages and ingredients; calculated formulation quantities, strengths, overages, batch factors, yields, tolerances and raw-material equivalencies.
• Scaled laboratory and pilot formulations to commercial batch sizes and assessed raw-material substitutions, manufacturing feasibility and formulation changes.
• Supported liquids, powders, capsules, creams, sprays, syrups and drops; aligned product structures, bills of material and ERP information with approved formulations.
• Compiled and reviewed product dossiers, specifications, COAs, Professional Information, Patient Information Leaflets, labels and packaging text.
• Verified and structured client information for a Mozambique regulatory project, preparing comparative tables, technical summaries and supporting dossier information.
• Worked with Production, QC, Warehouse, Packaging, NPD and clients to resolve technical and quality issues; also supported purchasing and led Health and Safety and First Aid activities.

Pharmacist Second in Charge at Heyns Apteek (2016 – 2017)

• Supported the Responsible Pharmacist with professional and operational management, dispensing, clinical checks, patient counselling and OTC care (From Schedule 1-6)
• Supported stock and cold-chain control, schedule-medicine management, health screening, staff guidance and pharmacy administration.

Independent / Relief Locum Pharmacist at Various community pharmacies (2015 – 2018)

• Provided relief cover across community pharmacies, adapting to different teams and systems while maintaining safe dispensing, counselling and continuity of care.
• Supported stock control, schedule registers, claims, administration and opening or closing responsibilities.

Community Service / Warehouse Pharmacist at South African Military Health Service (SAMHS) Depot (2014-02 – 2015-11)

Completed community service in pharmaceutical warehousing and distribution, supporting medicine supply to military hospitals (all South African Units) and authorised healthcare units.

• Received, checked, documented and quality-assured medicines, medical supplies and stock; maintained accurate inventory, batch, expiry, traceability and distribution records using an Oracle-based Warehouse Management System.
• Managed receiving-area activities, including stock-status identification, quarantine controls, segregation, approved storage, stock rotation, expiry follow-up and stock-location management.
• Supported stock takes, cycle counts, stock reconciliation, investigation of discrepancies, follow-up of outstanding orders, damaged stock, returns, supplier queries and credit notes.
• Picked, checked, packed and prepared pallets for dispatch, ensuring correct quantities, batch details, expiry dates and authorised documentation before distribution.
• Supported the controlled handling, documentation and distribution of Schedule 1–6 medicines in accordance with applicable legal, quality, security and traceability requirements.
• Took after-hours and night-shift pharmacist duties at 1 Military Hospital, Pretoria, dispensing inpatient, discharge and emergency medication orders.
• Resolved prescription queries with doctors, nurses and other clinical staff, while maintaining urgent medicine supplies, controlled-drug records, cold-chain requirements and clear shift handovers.

Intern Pharmacist at Dis-Chem Bracken Gardens (2013 – 2014)

• Offered an internship following regular work at the pharmacy during university holidays, where the team had become familiar with my work.
• From the second year of B.Pharm. studies, completed compulsory supervised practical-training hours during university holidays under the Responsible Pharmacist and tutor, Angelique Kalavitis.
• Completed supervised internship training in prescription dispensing, clinical and legal prescription screening, patient counselling, OTC recommendations, generic substitution and chronic-medicine support.
• Assisted with stock control, medicine ordering, expiry-date monitoring, cold-chain management, medical-scheme claims and dispensary workflow under pharmacist supervision.

Bachelor of Pharmacy (B. Pharm.) – North-West University, Potchefstroom (2009 – 2012)

Primary Care Drug Therapy – North-West University, Potchefstroom (2020 – 2023)