The Responsible Pharmacist (RP) is responsible for the compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of finished products for sale.
The RP is responsible for ensuring that only quality products, which have been produced, documented, tested and stored in accordance with cGMP are released to the market. If the above mentioned function is delegated, it is the responsibility of the RP to ensure that this has been done via an appropriate delegation process and to ensure the deputies are adequately trained.
Advise the MCC who is authorised to communicate with the MCC.
Ensure a deputy RP is appointed for xxxxx and is present on site in the RP’s absence.
Is responsible to the Medicines Control Council for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) relating to the sale, control of the manufacturing and distribution of medicines, scheduled substances or medical devices.

Is responsible to the South African Pharmacy Council for compliance with the provisions of the Pharmacy Act, (Act 53 of 1974) relating to the sale, control of the manufacturing and distribution of medicines, scheduled substances in scope of the profession of a pharmacist.

Is responsible for communication with the MCC on all GMP matters.

Responsible for ensuring all MCC and SAPC licenses are current
Initiate and co-ordinate all recall and withdrawal activities, which should involve the head of Quality Management.
Ensure that regular audits, self-inspections and spot checks are conducted by experienced staff
Ensure compliance to the following obligations prior to release of a “batch”:
The QA release pharmacist is delegated to in writing
All prescribed requirements of the registration of the medicine and manufacturing license are met,
The principles of cGMP have been followed,
The principal manufacturing and testing processes have been validated,
All necessary quality control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records,
Changes and deviations in manufacturing, packaging or quality control are notified in accordance with a well defined reporting system before any product batch is released,
Additional sampling, inspection, tests and checks are conducted or initiated, as appropriate, to cover changes or deviations,
All necessary manufacturing, packaging and associated documentation are completed and endorsed by suitably authorized staff trained in the concept of Quality Assurance and Good Manufacturing Practices
The release parameters on the COA provided by QA are all within specification and the COA is
signed by the QC supervisor

Regular audits, self-inspections and spot checks are conducted by experienced staff,
All relevant factors are considered, including any not specifically associated with the output batch directly under review, (e.g. calibration and maintenance records, environmental monitoring),
The legal requirements regarding imported products are fully met, by ensuring testing is conducted to verify the requirements and other tests to assure quality of the products,
To maintain a register (or equivalent) as a record of product batches certified by the release pharmacist on batch release,
To retain reference samples of each product batch at the site of manufacture for a period of time in compliance with guidelines
Review and approve APQRs for all locally manufactured products and for imported bulk packed locally.
Ensure all relevant persons receive appropriate training related to the relevant pharmaceutical activities and assist in cGMP and SOP training as required.
Ensure adherence to SOPs and cGMP guidelines.
Assess and approve change control requests which could impact on product quality.
Ensure that customer complaints received are assessed, investigated and concluded timeously. This function is delegated to the quality compliance pharmacist, but all critical complaints are reported to the RP for assessment and evaluation.
Ensure the safe and effective storage and keeping of medicines and scheduled substances.
Review and sign dossiers before submission to MCC as per local and global requirements.
Ensure artwork and promotional material meet regulatory requirements.
Ensure site change plan is created and implemented on site as owner of Site Change Champion porfolio.
Preparation for MCC audits and managing all activities of the audit including preparation of the response.
Conduct C GMP and for cause audits of other sites and third party contractors as and when required.
Participate in management escalations.
Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)

is fully compliant with all legislation requirements, as well as internal & global expectations.

There is continuous supervision of a registered pharmacist, and when appropriate delegation is in place to experienced and appropriately trained and qualified staff.
Relevant and timely training implemented for all associates as per SOP requirements and appropriate training records as confirmation.
Evidence of regular monitoring, self-inspection and spot-checks to validate adherence to SOP’s and cGMP guidelines.
Implementation of site change plan.
No withdrawal of manufacturing license due to GMP related activities.

Education:
Bachelor of Pharmacy
Registered Pharmacist in South Africa

Languages:
Proficiency in Business English (written and spoken)

Experience:
Minimum 5 years managerial experience in the production, quality and/or regulatory functions in a manufacturing pharmaceutical companyWorking knowledge of cGMP & all relevant SOP’s