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RESPONSIBLE PHARMACIST - 359232
Healthcare/ Pharmacies / Hospitals / Medical / Emergency Services
Wage / Salary:
R - Market Related - P/M (Per Month)
RESPONSIBLE PHARMACIST: Overview of Role to cover
Returned or rejected goods
The objective of the SOP is to ensure that the company is well-managed by a pharmacist and that all the requirements of the Pharmacy Council, Medicine Control Council
To ensure registration of the Responsible Pharmacist and company with the SAPC.
To ensure that the name of the RP is prominently displayed over the entrance of the premises.
To ensure that the daily activities are conducted under the continuous supervision of a pharmacist.
To ensure that a deputy pharmacist is in control of the facility should the RP be absent.
To ensure that all the directors are au fait with the latest ethical rules and agree to abide thereby.
To ensure that contracts exist between Holder of the Registration Certificate and 3rd party contractors stipulating where all responsibilities lie.
To ensure that medical representatives (if applicable) are correctly trained, carry all necessary authorisations and that all the relevant documentation is completed and handed in – Function delegated to distributor.
To ensure that all product complaints are investigated and identified as to the nature of the problem and is given the necessary attention.
To ensure that product complaints are noted and kept on file and followed up in a procedurally correct manner.
To perform trend analysis on all complaints.
To approve investigation report and corrective actions due to complaints.
To be able to handle a recall according to correct procedure.
To ensure that the distributor records the batch numbers on all invoices and that batches are traceable in the event of a recall.
To take the final decision on a recall.
Returned or rejected goods
To ensure that goods returned to the Distributor are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
To ensure that goods to be rejected or reworked are handled in a procedurally correct manner.
To be responsible for final decision (after consultation with the distributor and the manufacturer) to re-analyse, repack or destroy any returned/rejected goods.
GMP / GHP / GWP / GLP / GDP
To ensure that all employees are conversant with the system laid down for using and following the standard operating procedures.
To identify the need of and ensure regular GMP training for employees. To ensure the professional competence of the trainer and that each employee files its training records.
To ensure that inspection audits are performed on all third party contractors whereby it is established that:
All manufacturing operations are carried out in accordance with approved, written GMP and manufacturing procedures.
The products as manufactured meets the specifications as per the ZA CTD.
That the specified quality is maintained during storage and transport.
That a contract packer and manufacturer have adequate facilities and that written systems are adhered to until final release of the packaged product.
That all analytical methods are validated.
That manufacturing processes are validated.
That the manufacturer has an ongoing stability program and that the first three production batches are put onto stability.
All cleaning logs and temperature logs are completed.
That regular reconciliations are performed on printed packaging materials.
To ensure that the distributor disposes and destroys all scheduled medicines in a correct manner in order not to be a health hazard.
To ensure that an adequate pest control program is in place at the distribution facility, using acceptable food grade bait, and to ensure that precautions are taken to ensure that product contamination does not occur.
To ensure that self-inspection audits are performed and any deviations are recorded and followed up.
To ensure that products on arrival are placed in quarantine, imported products sampled for re-testing, sent for re-testing, and kept in quarantine until released.
To ensure that imported products are sampled for testing & retention samples.
To ensure that regular stock reconciliations are performed at the distributor.
To ensure that necessary updates are made to the ZA CTD dossier according to the latest requirements of the SAHPRA.
To ensure that the Registrar of Medicines is informed of changes to the ZA CTD.
To ensure that master documentation exist for each product and is kept up to date.
To ensure that all master documentation complies with the ZA CTD and is current.
To ensure that all changes are controlled and monitored.
To ensure that with certain changes, the manufacturing process of the first three batches is validated, and that the first three batches are placed on stability for a minimum period of the approved shelf-life.
To ensure that with new registrations the shelf life is confirmed by continuing the stability program on two batches for at least 24 months.
To ensure that a record is kept of all stability studies performed.
To ensure that adequate retention samples of all raw materials and products manufactured are taken by the contractor and kept as retention samples in the archives for reference.
To ensure the location of ZA CTD master documents and copies thereof are recorded, maintained and controlled in a correct manner.
Documentation and general
To release the final products to the market as required on medicines according to procedure.
To proof read all printed packaging material and sign off for printing.
To approve and authorise all advertising material.
To approve and sign off annual product reviews on each product according to the SOP.
To ensure that all SOPs are regularly revised and updated, and then correctly authorized; to approve SOPs.
The RP may delegate any of the above tasks to the deputy RP at his own discretion. However, the responsibilities stay with the RP.
Responsible for pharmacovigilance activities.
Approval of deviation reports.
Professional representation of Responsible Pharmacist
Contact person for third parties in regard to any QA topic.
Liaise with third parties regarding change control (support in providing documentation for registration with SAHPRA, coordination and follow-up of registration / implementation, follow-up on completing commitments submitted to SAHPRA).
Compare all batch manufacturing documents and release tests and specifications for compliance with the master ZA CTD and documents before signing for release of a batch.
Complete batch release documentation for review and signature by the Responsible Pharmacist or Deputy Responsible Pharmacist to release.
Managing and Maintaining of Quality Assurance Systems
Maintaining complaint register
Maintaining deviation/OOS records
Maintaining release records
Coordinating of change control and maintaining of change control records
CAPA management (maintaining of CAPA register and support of RP in following-up on implementation and review of efficacy of CAPAs)
Compiling of PQRs according to SOP
Review and update of SOPs
Monitoring of archiving process
Follow-up on annual stability and maintaining of stability plan and stability data records
Regular GMP training and training on changes of applicable regulations and law; maintaining personal training record