Responsible Pharmacist and QA Lead Position

SA Health along with the Mpeta Group is looking for a Dynamic individual who is able to do a dual role of both the Reposnsible Pharmacist and a Quality Assurance Lead (QA)

SA Health Protecting Services is a registered Medical device and Pharmaceutical wholesaler with with SAHPRA and SAPC and its sister company Mpeta Group is a SAHPRA section 22 licensed Medicinal cannabis cultivation facility.

The Job will be split between the two entities where the RP and QA role will be prodominatly at Mpeta Group which is a SAHPRA licensed Medicinal Cannabis Cultivation Facility.

The Individual will also be required to be a assitant pharmacist at SA Health as well as asssiting with QA requirements for both entities.

Qaulity Lead - QA 

Lead Key Tasks 

1.    Co-ordination of the Head of Quality Control Responsibilities
•    Approve or reject materials.
•    Evaluate batch records.
•    Ensure all testing performed.
•    Approve specifications, etc.
•    Approve and monitor contract analysis.
•    Maintain department, premises and equipment.
•    Validations performed.
•    Initial and on-going training.
2.    Co-ordination of the Duties of the Quality Control
•    Approving or rejecting all components, product containers, closures, in-process materials, packaging material, labelling and final products.
•    Review production records.
•    Ensure that if errors have occurred, that they have been fully investigated.
•    Approving or rejecting products manufactured, processed, packed or held under contract by another company.
•    Approving or rejecting procedures or specifications.
3.    Quality Assurance
•    Authorization of written procedures and other documents.
•    Monitoring and control of the processing ( GMP) environment.
•    Plant hygiene.
•    Process validation.
•    Training.
•    Approval and monitoring of suppliers.
•    Approval and monitoring of contract manufacture.

•    Designation and monitoring of storage conditions.
•    Retention of records.
•    Monitoring of compliance to GMP.
•    Inspection, investigation and taking samples.

4.    The QA RESPONSIBILITIES
•    The QA must ensure that each batch was produced and tested according to GMP and Licensed conditions.
•    The QA must sign a register to state that the above has been performed satisfactorily before product is released (QA certification).
•    Product Quality Review performed in a timely manner and accurate ( Quarterly)
•    Before certifying a batch prior to release the QA should ensure that at least the following requirements have been met:
o    The batch and its results comply with the provisions of the purchaser , the product specifications and quality standards.
o    Cultivation , primary processing and testing processes have been validated.
o    Account has been taken of the actual production conditions and manufacturing records (NB The Heads of Production and QC are ultimately responsible for performing this task)
o    Deviations or planned changes in production or QC have been authorized by the persons responsible in accordance with a defined system
o    Changes requiring variation to the product specifications have been documented and authorized by the relevant authority
o    All necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
o    All necessary production and QC documentation have been completed and endorsed by the staff authorized to do so
o    Non-conformance management , CAPA ( Corrective Action , Preventative Action) and Risk Management
o    All audits have been carried out as required by the quality assurance system
o    Product Recall and Product Returns management

The QA should in addition take into account any other factors of which they are aware of which are relevant to the quality of the batch 

While guidance is laid down in the Standard Operating Procedures, a certain degree of discretion is expected. 
This particular role requires the individual to co-ordinate his or her colleagues and requires a reasonable working knowledge of IT systems. 

Repsonsible Pharmacist - RP

LEGAL COMPLIANCE

licensing requirements (DoH; SAPC; SAHPRA)

Personal accountability

security control and sale of medicines (unscheduled and scheduled) compliance with pharmacy legislation and marketing code HUMAN

RESOURCE MANAGEMENT

direct personal supervision Delegation letters

Job Descriptions (JD) Organogram

Appropriate knowledge and experience

Effective GMP training ETHICAL CONSIDERATIONS Integrity (personal, data, product, premises) PharmacoVigilance (PV) duties

Adverse Drug Reaction Reporting (ADRR) / Adverse Event Reporting (AER) Continuing Professional Development (CPD)

Reporting company non-compliance Recalls

Continuous improvement QUALITY MANAGEMENT SYSTEM Control of manufacturing and distribution of medicines Standard Operating Procedure (SOP) training

Implementation of comprehensive Quality Management Systems (QMS) / Pharmaceutical Quality System (PQS) requirements across the company

Self-inspections (SI) and audits

Contract Giver activities REGULATORY COMPLIANCE Product artwork and labelling

Dossier submissions and maintenance Supervision of all employed pharmacists

Annual fees: licences, products, registered persons S6 and alcohol registers

Launches

FUNCTION: ROLES AND RESPONSIBILITIES AS A RESPONSIBLE PHARMACIST- SECTION 22 MEDICINAL CANNABIS CULTIVATION

Please note that a futher detalied Job description will be shared on second round of discussions the above is an over view.

Registered as an active, practicing pharmacist in South Africa, with no outstanding payments/ fees.

Police clearance certificate

Not registered as a Responsible Pharmacist at any other registered / licensed/ active pharmaceutical site of any nature

NQF: Level 6 

QA Lead- Must have experience in Quality Assurance , ISO 13485, GACP and GMP experience

TCT R850 000 Per Annum

Further benefits to be discussed during Interview stage