SUMMARY:
To be responsible for regulatory compliance so as to ensure the overall running of the manufacturing pharmacy complies with all regulatory & statutory requirements and that the operation and all outsourced functions, are conducted in accordance with Good Pharmacy Practice , Good Manufacturing Practice , Good Warehousing Practice and Good Distribution Practices . To uphold and enforce company policies and procedures.
POSITION INFO:
Qualification and Requirements:
Minimum qualification required:
- B.Pharm Degree or equivalent
- South African Pharmacy Council registration
- 5 Years prior experience as a manufacturing Responsible Pharmacist
RESPONSIBILITIES:
Legislative compliance
- Responsible for all communication with the relevant regulatory authorities
- Ensure registrations with all regulatory authorities are up to date
- Oversee and ensure all manufacturing processes and procedures strictly adhere to GMP guidelines and regulations to maintain high-quality standards
- Staying current with pharmaceutical regulations and industry standards, and ensuring the facilityâs operations meet all relevant legal requirements
Continuous Improvement Processes Operation
- Identifying opportunities for process optimization and participating in continuous improvement initiatives to enhance product quality and operational efficiency
- To manage Quality on site by ensuring that SOPâs are relevant, effective and current
- To conduct self- inspection audits and preparing for audits by the third parties
- To ensure that quality standards and requirements as defined by the Quality System are maintained at all times
- A statutory duty to ensure quality control and that the company is at all times above reproach.
To keep the quality standard contemporary, through effective monitoring of product and methods, the environment and new technologies.
Patients are properly protected and that all manufactured products meet appropriate requirements for safety, quality, efficacy and company policy
- To ensure that the Company has a manufacturing license and must manufacture medicines so as to ensure that they are fit for their intended use, comply with the prescribed requirements of the registration dossier and do not place patients at risk due to inadequate safety, quality or efficacy
- To support this quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control
- The Quality Assurance system should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related
- To evaluate and make final decisions regarding batch disposition
- Provide pharmaceutical support in decision making processes
- Ensure continuous QA presence during manufacturing and optimal functioning of production lines, keeping down times to a minimum
- To load new codes and formulations on the SYSPRO ERP system
- Concerning new products, the processes are translated to production instructions within the required period. Assist with trails and the manufacture of products to ensure that they comply with the company quality policy
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- To ensure that the site is pest-free at all times. Liaise and ensure proper documentation concerning the outsourced Pest Control Company
- Active involvement in the Site Management Team
Financial
- Effective utilization of resources to keep processes effective
- Enforce quality assurance through regulatory and statutory compliance to ensure safety, quality and efficacy and have minimum reworks and rejects
- Apply Commercial thinking to simplify process, methods and production flow
- To manage all budgets related to departmental training, maintenance and cleaning
Customer Service
- Managing product complaints and initiating recalls if necessary, to address any quality issues or safety concerns
- Complaints, recalls and rejects are to be logged, investigated and resolved timeously
- All queries are followed up and resolved in the shortest possible timeframe within policy framework
- A professional attitude is displayed when responding to a customerâs needs
- Methods for improving customer services are proposed, developed and continuously updated
- Internal and external customers are constantly updated as to the progress of their queries
