To support, administer and maintain systems that ensure regulatory compliance and the quality.<\/p>\n
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Job Title: Job Title Quality Assurance Coordinator (Fixed Term Contract)<\/strong> Job Summary:<\/strong> Lot Releases:<\/strong> laboratories:<\/strong> Reporting to Divisional Manager:<\/strong> QA Complaints:<\/strong> Documentation:<\/strong> Audits:<\/strong> Stability:<\/strong> Stability:<\/strong> General:<\/strong>
\nLocation:<\/strong> Westlake, Western Cape, South Africa
\nReference #:<\/strong> #QACFTC
\nContract Type:<\/strong> Contract 6 Months
\nSalary:<\/strong> Market Related<\/p>\n
\nKEY RESPONSIBILITIES:<\/strong>
\nFocus areas of key responsibilities can be re-allocated as per business requirements
\nOperations<\/p>\n
\n\u2022 Create, review and update Lot Release Forms per product: Product Trend Charts per product, Printed Packaging Material inspection reports, Bulk inspection reports and any other related QA forms, templates and registers pertaining to lot release.
\n\u2022 Coordinate the timeous sampling of incoming goods at the contract distributor and\/or packer
\n\u2022 Coordinates the analytical reference standards at the various contract laboratories
\n\u2022 Coordinate the timeous testing for post importation requirements and documentation thereof with contract<\/p>\n
\n\u2022 Compile and maintain the samples register when the need arises
\n\u2022 Liaise with Third party contractors when the need arises.
\n\u2022 Coordinate, compile and review all batch documentation relating to the lot release of all products – manufacturing, packaging and analytical records – in compliance with registered dossiers
\n\u2022 Performs Bulk material inspections before packaging and liaise with contractors, maintain registers
\n\u2022 Performs final packed product inspection, maintains the product trend charts and updates the lot release summary for all products on an ongoing basis
\n\u2022 Coordinates the timeous final product release to market of all products by the Finished Product Release Pharmacist
\nJob Title Quality Assurance Coordinator (Fixed Term Contract)
\nPurpose of position To support, administer and maintain systems that ensure regulatory compliance and the quality.<\/p>\n
\n\u2022 Ensuring starting materials and bulk products are promptly released at contract packer
\n\u2022 Fields on-line issues and deviations at contractors to avoid an impact to quality and regulatory compliance of company products. May provide reporting in this regard.
\n\u2022 Field Product Re-works (Redress) with contractors to ensure compliance to quality and regulatory requirements of the company and as dictated by the dossier.
\n\u2022 Preparation, compiling and maintenance and review of new business development projects (new products). Ensure preparation for new Launches; internal set-up and preparations with post importation laboratories.<\/p>\n
\n\u2022 Handles and logs quality complaints from the trade and the sales force
\n\u2022 Communicate technical complaints to third party contractors and coordinate the quality investigation
\n\u2022 Compile summary reports for management review
\nDeviations and Root Cause Analysis
\n\u2022 Raise and record any deviations as and when the need arises.
\n\u2022 Ensure root cause analyses are conducted for any deviations raised where applicable
\n\u2022 Follow up on fielded open deviations until they are closed out.
\n\u2022 Liaise with suppliers on deviations where they are involved before close out where necessary.
\n\u2022 Provide progress reporting to the management team on current deviations when the need arises.
\nTraining
\n\u2022 Conducts training and presentations when the need arises<\/p>\n
\n\u2022 Assist with the maintenance of the contractor master documentation repository at Pharma Dynamics ensuring that the company is in regulatory compliance with its current MCC licensing conditions for manufacture, packing and testing as the need arises.
\nThis pertains to master copies of product batch manufacturing documents(BMR), batch packing documents(BPR), analytical methods, product specifications, stability protocols (Note that RA assists with sourcing of BMR and BPR).
\n\u2022 Maintain the internal QA documentation repository at Pharma Dynamics ensuring that the company is in regulatory compliance with its current MCC licensing conditions for manufacture, packing and testing (templates, forms, charts registers and reports) when the need arises
\nUpdate the company Electronic Document Management System with all relevant information
\n\u2022 Compile monthly progress reports when the need arises
\n\u2022 Co-ordinate and monitor change controls through recording changes on a central document register and tracking it to implementation and close-out when the need arises.
\n\u2022 Report and review temperature monitoring results post importation.
\n\u2022 Report and monitor out-of-specs; investigate and conduct a risk assessment when the need arises.
\n\u2022 Record and maintain the central data system on CAPAS and follow up until close-out when the need arises
\n\u2022 Compile and review technical quality agreements (TQA) when the need arises.
\nEnsure current and authorized technical agreements are implemented and recorded with each supplier or third-party contractor<\/p>\n
\n\u2022 Assist with third party contractor site inspections when the need arises.
\n\u2022 Assist with preparation of reports on audit findings and follow up to close out when assisting with audits
\n\u2022 Participate and assist with local inspections on PD by the SAHPRA and\/ or any other regulatory body.
\nStandard Operating Procedures
\n\u2022 Assist with the maintenance of the SOP program data base ensuring that the company is in regulatory compliance with its current MCC licensing conditions when the need arises
\n\u2022 Write SOP\u2019s when QA is the subject expert and GMP related SOP\u2019s when the need arises
\n\u2022 Review and update SOP\u2019s ensuring that the SOP data base is always current and valid as the need arises.
\nProduct Quality Reviews
\n\u2022 Coordinates and maintains the Product Quality Review (PQR) program when the need arises.
\n\u2022 Liaise with contractors and source, collate and review all relevant batch documentation for the released product during the review period, stability data, and any other GMP documentation required as per the SOP
\n\u2022 Compiles, review and maintain the related register, logs and reports. Conduct the review and compile the report when conducting reviews.<\/p>\n
\n\u2022 Coordinates and maintains the stability program and compiles, review and maintain the related register, logs and reports \u2013 covering the program on Bulk material as well as Finished Packed Product and Export products when the need arises
\n\u2022 Captures all stability study data generated and compiles stability summary reports<\/p>\n
\n\u2022 Coordinates and maintains the stability program and compiles, review and maintain the related register, logs and reports \u2013 covering the program on Bulk material as well as Finished Packed Product
\n\u2022 Captures all stability study data generated and compiles stability summary reports<\/p>\n
\n\u2022 Assist the RA department with information as and when required.
\n\u2022 Provide any budget related information as and when required. Ensure any costings provided are as accurate as practically possible.
\n\u2022 Coordinates Destructions; liaise with contractors and compile and maintain records.
\n\u2022 Coordinate and reconcile destruction requests from suppliers when required.
\n\u2022 Coordinate translations when required.
\n\u2022 Prepare and review invoices for approval.
\n\u2022 Perform any ad-hoc duties as required<\/p>\n