Permanent Quality Assurance Pharmacist Needed Urgently
Quality Assurance Pharmacist Needed Urgently
Job Type: Permanent
Company/Employer: Execustaff Recruiting Services SA (Pty) Ltd
Job Title: Quality Assurance Pharmacist Needed Urgently
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 contracts exist between the company and 3rd party contractors stipulating where all responsibilities lie.
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.
To ensure all SAHPRA / DOH and SAPC licenses remain up to date and inform RP is the need arises for renewal.
To ensure all retention fees are paid timely.
To ensure Site Master File is updated and submitted to subsequent authorities in a timely matter.
QUALITY MANAGEMENT SYSTEM:
- Establish the quality management system to describe how the company complies with GMP/GWP/GHP/GDP etc.
- Keep current with good manufacturing practices, and applicable to the mission of the company.
- Review and updating of Standard Operating Procedures when applicable
RECEIVING AND RELEASE OF STOCK:
- To check all relevant documentation in order to formally release final packed product for distribution where applicable.
- To release batches to the market according to correct procedure.
- 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.
RETURNED / REJECTED GOODS:
- To ensure that goods returned to the company by the distributor on behalf of the company 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.
- To be responsible for the final decision to re-analyse, re-pack or destroy any returned/rejected goods.
- 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.
- 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 take the final decision on a recall with SAHPRA after consultation with the Responsible Pharmacist.
- To ensure that SAHPRA is immediately of any possible withdrawal of unwanted medicine from market.
- To ensure that all logs are completed by the warehouse staff
- To ensure all loggers used are calibrated as per requirements.
- To ensure that proper agreements are in place with suitable company to do temperature mapping and temperature logger calibrations.
- To ensure that proper agreements are in place with suitable air-conditioning service company.
CLEANING AND WASTE CONTROL:
- To ensure adequate processes are followed to ensure good housekeeping is upheld throughout the warehouse, offices, kitchen 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 proper agreements are in place with suitable waste control company.
- 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 proper agreements are in place with suitable pest control company.
TRANSPORT / COURIERS:
- To ensure that proper agreements are in place with suitable courier companies.
- To ensure that general maintenance of building and all equipment is done by Health and Safety Officer as per stipulated standard operating procedures.
- To ensure that self-inspection audits are performed, and any deviations followed up.
- To audit for compliance to policies and procedures: on paper vs. practice internal and external
- Report on the performance of the quality system, including trends, that help
- decision making for targeted actions by top management
- 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 CTD.
- that the specified quality is maintained during storage and transport.
- that a contract packer has adequate packaging facilities, and that written systems are adhered to until delivery of the final packaged product for release for distribution.
PACKAGING AND MARKETING MATERIAL:
- To check and sign all components used in product packaging to ensure it complies with CTD information
- To approve and sign off all advertising material and to ensure that the material complies with the marketing code.
- To ensure SOP training is provided to all employees on an ongoing basis.
- To ensure GMP training is provided to all employees on an ongoing basis.
- To attend training when applicable or requested by the Responsible Pharmacist / Managing Director.
- To ensure that all employees are conversant with the system laid down for using and following the standard operating procedures.
QUALITY MANAGEMENT MEETINGS:
- To inform management by reporting on process and system risks—and keep management informed.
- Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure.
- Candidate Requirements
- QA PHARMACIST / DEPUTY RESPONSIBLE PHARMACIST REQUIREMENTS:
- B Pharm Degree
- Registered as practicing pharmacist with SAPC.
- GMP experience minimum 2 year / onsite QMS training.
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