Junior Quality Assurance Pharmacist

 

Recruiter:

Glasshouse Recruiting

Job Ref:

CPT000241/Tracy

Date posted:

Tuesday, February 8, 2022

Location:

Johannesburg, South Africa


SUMMARY:

The main purpose of this position:

  • To assist in the release of pharmaceutical products for sale on the market to meet commercial objectives
  • To ensure that standards and columns are available for testing of product
  • To compile, review and maintain Standard Operating Procedures (SOP's) as well as the SOP dashboard on behalf of the Applicant
  • To manage all the courier of all samples, documents and related parcels on behalf of the Applicant
  • To manage master batch documents, executed batch documents and retention samples on behalf of the Applicant
  • To assist in the implementation and to manage and maintain an effective Quality Management System
  • To maintain the Artwork smartsheets
  • To maintain the stability data smartsheets
  • To maintain the PQR data smartsheets
  • To ensure that permits are applied for when requested
  • To request samples from the Third-Party Distributor when required
  • To assist with the tender applications


JOB DESCRIPTION:


Duties & Responsibilities include:

(But are not limited to)
  • To ensure that all executed batch manufacturing documents, packing documents, Finished Product (FP) Certificate of Analysis (CoA's), API certificate of analysis are received timeously from manufacturers
  • To review all executed batch manufacturing documents and packing documents against the current master documents and dossier specifications & limits
  • To review all FP CoA's, API CoA's of manufactured batches against the current master documents and dossier specifications & limits prior to release
  • To review and approve the post-importation CoA results for products which are imported
  • To review the retention samples sent by manufacturers for every batch that was manufactured against the documents supplied with the batch and against the current registered dossier information
  • To ensure that the release documents are completed fully by the Responsible Pharmacist prior to releasing products on the market
  • Once releases have been signed off by the pharmacist to ensure that the Third-Party Distributor is instructed to release the stock
  • To complete the release smartsheet so that all parties are aware of what products have been released
  • To review and approve master documents in line with the registered dossier
  • To maintain the Product Master File for each product in order so that the status of the current Master Document can be determined at any given time
  • Ensure that all SOP’s are current, reviewed regularly, updated when necessary and authorized
  • Ensure that the most recent SOP’s are uploaded to the dashboard and notifications are sent to start members to read and acknowledge the SOP
  • Ensure that questions are submitted to HR in order to load the SOP onto Policy Passport for training purposes
  • Assist in distributing controlled copies of standard operating procedures to the relevant staff members and areas of use
  • To create, update and maintain company legal documents (appointment, authorization and delegation letters, organogram, job descriptions and Site Master File)
  • To handle all complaints (Product quality and ADR’s) timeously once they have been. received from the market and follow-up on these and ensure they are closed timeously
  • To perform a trend analysis on all complaints, returns and deviations
  • To assist with the handling of recalls should any recall occur
  • To ensure that all critical QA related information is saved on the QA share server for reference
  • To conduct self-inspection audits on a regular basis, identifying deficiencies and proposing corrective actions
  • Perform vendor inspections in accordance with the company's SOP
  • Review APQR's "Annual Product Quality Reviews" received from the manufacturers and compile summary
  • Upload PQR data to the PQR smartsheet
  • To maintain a list of retention samples that is being held at the third party manufacturer
  • To ensure that standards are ordered and available for Post Importation testing based on monthly stock report     received from the laboratories
  • To maintain the artwork smartsheet, ensuring the only the most recent approved artwork, PIs and PILs are available For review
  • To apply for Schedule 6 permits when requested to do so by the procurement team, using the information available on the permit smartsheet
  • To assist the procurement team with the compilation of tender applications including ordering of required samples, filling out forms, printing of dividers, arranging for the application to be couriered
  • To manage stability programs initiated for all the marketed products as per SAHPRA requirement
  • Review/monitor stability results of each product/batch that is placed on stability
  • To courier post-importation samples back to the manufacturer for post-importation analysis (if no local FPRC exists)
  • To courier documents and related parcels.
  • Reviewal and Approval master documents.
  • Keep abreast of new developments in legislation, guidelines and recommendations of the various Health Authorities in Africa
  • Acquire and maintain technical knowledge and skills relevant to the position by keeping abreast of current literature and attending academic seminars/meetings with respect to new developments in the regulatory affairs and pharmacovigilance arena


Requirements:
  • Matric
  • BPHARM Degree
  • Completed Community Service
  • Registered with the South African Pharmacy Council
  • No experience required


Please email CVs to -house.co.za

 

NB! This job is now closed. You can apply for other jobs by uploading your CV.



 

 

 

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