Regulatory Affairs & Quality Assurance Pharmacist /Responsible Pharmacist

SUMMARY:
JOB SUMMARY

• Responsible to ensure that regulatory submissions and compliance are executed for all products.
• Develop and communicate with head office on the regulatory strategy and life cycle management of all products.
• Represent our company with the local authority and other external partners.
• At local level, provide and ensure quality oversight of activities in a defined scope (manufacturing / I&D).
• To ensure that all logs are completed by the distribution / warehousing facility e.g., temperature control, cleaning, maintenance etc.
• To ensure that disposal or destruction of medicines is correctly performed under proper control so as 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 followed up.
• To ensure that goods on arrival at the distribution facility are placed in quarantine, sampled for re-testing after importation, and retained in quarantine until formally released where applicable.
• To release batches to the market according to correct procedure.
• To check all relevant documentation to formally release final packed product for distribution where applicable.
• To ensure GMP training is provided to all employees on an ongoing basis.

POSITION INFO:
RESPONSIBLE PHARMACIST RESPONSIBILITIES
The Responsible Pharmacist contemplated in regulation 25(3) must:

• Ensure that they continuously supervises the pharmacy in which they have been appointed.
• Have appropriate qualifications and experience in the services being rendered by such pharmacy.
• Ensures that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with council.
• Notify council immediately upon receiving knowledge that he /her services as responsible pharmacist have been or will be terminated.

Take corrective measures in respect of deficiencies with regard to inspection reports of council or in terms of the Medicines Control Act. LEGAL

• To ensure registration of RP and licensing of the company with Authorities.
• To ensure name of RP is prominently displayed over entrance.
• To ensure that the pharmaceutical facility is conducted under the continuous supervision of a pharmacist (legal requirement).
• To ensure that a Designated Deputy RP (DDRP) is in control of the facility should the RP be absent.
• To ensure that contracts exist between Holder of Registration Certificate and 3rd party contractors stipulating where all responsibilities lie.
• To approve and sign off all advertising material and to ensure that the material is legal.
• To ensure that directors (when applicable) are au fait with the latest ethical rules of SAPC, the SA Guide to GMP and sign agreements to abide thereby.

COMPLAINTS

• 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 involving "adverse drug reactions" are reacted upon and followed up without delay.
• To ensure that product complaints are noted and kept on file and followed up in procedurally correct manner.