Junior Quality Assurance Pharmacist

Recruiter:

Glasshouse Recruiting

Job Ref:

CPT000241/Tracy

Date posted:

Tuesday, February 8, 2022

Location:

Johannesburg, South Africa

JOB 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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