Our Client is looking for a QA pharmacist to assist and oversee all the quality assurance arrangements and report to senior management. The QA pharmacist will also assist the responsible pharmacist. The right Candidate would need to have 5 years experience in QA.

Quality Assurance:

• Review departmental SOPs
• Manage all QA departmental functions as listed, but not limited to:
• QA document control
• Approve and manage approved service providers’ list
• Liaise with service providers regarding QA matters
• Non-conformance (Deviations and OOS) documentation and investigations
• CAPA
• Change Controls
• Process validations
• Method validations
• Product Quality Reviews
• Risk management to ensure that any risk that may impact the quality of the product are appropriately assessed, controlled, communicated, and reviewed.
• Schedule and administrate quarterly Quality Management meetings.
• Approval of specification sheets for release

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.

RECALL

• To be able to handle a medicine recall or withdrawal according to correct procedure.
• To ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.
• To ensure that SAHPRA is immediately of any possible withdrawal of unwanted medicine from market.

RETURNED / REJECTED GOODS

• To ensure that goods returned to the HCR by the distributor on behalf of the HCR are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
• To ensure that goods due to be rejected are handled in a procedurally correct manner.

GMP/GWP/GHP

• 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 meet the specifications of the registration dossier.
• that the specified quality is maintained during storage and transport.
• that a contract packer has adequate packaging facilities, and those written systems are adhered to until delivery of the final packaged product for release for distribution.
• 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 check all relevant documentation in order to formally release final packed product for distribution where applicable.

• B. Pharm degree
• Registered with the South African Pharmacy Council
• Good computer literacy
• Knowledge of cGxP regulations
• Bilingual: English and Afrikaans

EXPERIENCE REQUIRED

• Minimum 5 Years QA experience
• SOP and master QA document compilation/control
• Electronic Document Management System for eCTD eg DocuBrigde or Extedo preferable
• RA understanding preferable

SKILLS REQUIRED

• Strong Communication Skills
• Ethical principles and behaviour
• Extensive support
• Deadline driven
• Customer Focus
• Can work well under pressure
• Detail oriented
• Good analytical skills