Responsible Pharmacist - SAPC - Warehousing - East Rand

Job Masters; South Africa; On-site; ZAR 400,000 - 600,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Responsible Pharmacist to oversee QA processes and ensure compliance with regulatory standards. The position requires a qualified individual with experience in ISO 9001 systems management and auditing. Responsibilities include maintaining quality documentation and ensuring the effective handling of pharmaceutical products while liaising with stakeholders for compliance. This role offers exposure to various compliance aspects, audits, and training within a dynamic environment.

Qualifications

• Registered pharmacist with SAPC and ISO 9001 knowledge.
• Minimum 2-3 years experience in Quality Systems Management.
• Valid SA driver's license with own vehicle.

Responsibilities

• Manage pharmaceutical operations and quality management systems.
• Ensure compliance with regulatory requirements and licensing.
• Plan and conduct internal quality audits.

Skills

Quality Systems Management

Auditing

Regulatory Compliance

Education

Qualified Pharmacist

Matric / Grade 12

Job description

Responsible Pharmacist SAPC Warehousing East Rand

Manage and maintain the pharmaceutical operations in accordance with SAHPRA, SAPC, company, and client requirements. Oversee the quality management system (QMS) documentation, records, processes, and procedures.

Minimum requirements :

• Matric / Grade 12
• Qualified and registered pharmacist with ISO 9001 knowledge
• Minimum 2-3 years experience with ISO 9001 Quality Systems Management and auditing
• Valid SA driver's license and own vehicle
• Willing to work after hours if necessary
• Warehousing experience is beneficial

Job description : General

• Maintain certification against ISO 9001 and relevant pharmaceutical licenses
• Implement, manage, and maintain procedures for a successful QMS system
• Manage corrective and preventive actions (CAPAs) from audits
• Compile QMS reports and provide feedback to management
• Identify corrective actions and opportunities for improvement
• Promote awareness of the QMS within the business
• Set up and facilitate QMS meetings
• Maintain QMS documentation and filing
• Prepare and schedule management review meetings
• Perform administrative tasks and general housekeeping

Pharmaceuticals

• Must be registered as a pharmacist with SAPC
• Liaise with SAPC for compliance and licensing
• Ensure proper handling, storage, and distribution of pharmaceutical products
• Control access to scheduled products and ensure delivery only to licensed entities
• Maintain contracts and SLAs with third-party distributors and service providers
• Ensure all clients possess necessary licenses and registrations
• Ensure regulatory compliance in procurement, storage, and disposal of medicinal and medical products
• Maintain storage control and documentation for Schedule 5 and 6 products
• Purchase and keep reference books as stipulated by SAPC
• Sample imported products and keep retention samples as per instructions
• Assess third-party distributors and transporters for compliance
• Report improvement needs to management
• Act as Pharmacovigilance Responsible Person and manage ADR reporting
• Oversee pharmaceutical warehouse operations, including inventory control and stock management
• Ensure occupational health and safety compliance
• Document any out-of-limit situations and report to QA
• Ensure personnel working in storage areas are properly trained
• Control access to restricted storage areas
• Maintain accurate records of pharmaceutical receipt, storage, and transfer
• Participate in CPD programs and ensure pharmacist coverage in the absence of the Responsible Pharmacist
• Ensure availability of reference sources as per regulations

Training

• Plan, schedule, and conduct QMS training sessions
• Manage training records according to company procedures

Audits

• Plan and conduct internal quality audits
• Manage audit follow-ups and corrective actions
• Coordinate with regulatory bodies on audit schedules and requirements
• Manage and prepare for customer audits