Responsible Pharmacist (Hay Level 17/D2) (2Posts) (Internal & External) at NECSA

Key Performance Areas:

PRODUCT RELEASE:

• Control the manufacture, sale and distribution of products
• Ensure quality standards, processes and specifications align to cGMP requirements
• Ensure production activities and personnel comply with cGMP and relevant standards and guidelines
• Manage and control the process of quarantine, sampling, release of intermediates and finished products
• Oversee batch review and final accountability for release of raw materials, packaging materials and finished products
• Ensure appropriate storage and storage conditions for materials and products
• Act as custodian of retention samples as representative samples of batches sold

LEGAL AND REGULATORY COMPLIANCE

• Manage licensing requirements as per DoH, SAHPRA and SAPC requirements.
• Advise NTP on the impact of new legislation on current business.
• Ensure that marketing/sales activities are compliant with the various laws and codes.
• Review and approve promotional materials to ensure compliance with local regulatory/ legal requirements.
• Manage the control and sale of medicines.
• Oversee dossier management/maintenance and submissions to the authorities.
• Ensure timely payments of relevant annual fees for the pharmacy, products and pharmacists.
• Serve as member of the Change Control Committee.

PRODUCT AND PROCESS PERFORMANCE

• Ensure GMP guidelines are introduced into the facility processes to comply with regulatory requirements.
• Ensure implementation and maintenance of comprehensive pharmaceutical quality systems (PQS) and quality management systems (QMS) in the facility. 
• Oversee the evaluation of batch records and the final release of the product.
• Oversee self-inspections, audits and compilation of audit reports with corrective and preventative actions to expedite timely closure.
• Review annual quality product reviews.
• Review the trend analysis for key quality parameters.
• Manage the deviation and CAPA processes in the facility.
• Ensure all customer complaints are recorded, investigated and CAPAs put in place and that customers are given feedback relating to the investigations.
• Oversee the change control system in the facility.
• Manage the product recall process and conduct mock recalls.
• Manage all contractors and suppliers of materials and services through establishment of agreements.
• Provide guidance on compliance matters to personnel.
• Enforce integrity of behaviour of NTP personnel by reporting non-compliances.
• Maintain specified environmental controls for manufacturing of products.
• Act as pharmacovigilance officer for the site (for NTP and imported products)
• Maintain a stability program for manufactured products.

SOP AND DOCUMENTATION MANAGEMENT

• Ensure only personnel with appropriate knowledge and experience are appointed in key positions.
• Prepare, update, review and approve facility SOPs, reports and documents.
• Ensure facility documents are current.
• Ensures the facility is compliant to cGMP requirements.
• Ensure effective training of personnel in GMP, relevant guidelines and topics with associated training records.
• Review new guidelines, external inspection reports and current trends to keep site inspection ready.
• Ensure calibration status of equipment and instruments is current.
• Establish and maintain a master validation plan.

Requirements

Minimum Qualifications and Experience:

• B.Pharm degree or equivalent.
• Registered as a pharmacist with SAPC.
• 8 years in a Pharmaceutical Manufacturing Industry (with experience in Production and Quality Assurance)
• 4 years Management experience is essential.
• Experience as Responsible Pharmacist.
• Pharmacovigilance experience.