Job Title Quality Assurance Coordinator (Fixed Term Contract)

Pharma Dynamics

Western Cape, South Africa

6 MonthsContract

Aug 13

To support, administer and maintain systems that ensure regulatory compliance and the quality. KEY RESPONSIBILITIESFocus areas of key responsibilities can be re-allocated as per business requirementsOperationsLot Releases 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. Coordinate the timeous sampling of incoming goods at the contract distributor and/or packer Coordinates the analytical reference standards at the various contract laboratories Coordinate the timeous testing for post importation requirements and documentation thereof with contract laboratories Compile and maintain the samples register when the need arises Liaise with Third party contractors when the need arises. 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 Performs Bulk material inspections before packaging and liaise with contractors, maintain registers Performs final packed product inspection, maintains the product trend charts and updates the lot release summary for all products on an ongoing basis Coordinates the timeous final product release to market of all products by the Finished Product Release PharmacistJob Title Quality Assurance Coordinator (Fixed Term Contract)Purpose of position To support, administer and maintain systems that ensure regulatory compliance and the quality.Reporting to Divisional Manager: QA Ensuring starting materials and bulk products are promptly released at contract packer 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. Field Product Re-works (Redress) with contractors to ensure compliance to quality and regulatory requirements of the company and as dictated by the dossier. 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.Complaints Handles and logs quality complaints from the trade and the sales force Communicate technical complaints to third party contractors and coordinate the quality investigation Compile summary reports for management reviewDeviations and Root Cause Analysis Raise and record any deviations as and when the need arises. Ensure root cause analyses are conducted for any deviations raised where applicable Follow up on fielded open deviations until they are closed out. Liaise with suppliers on deviations where they are involved before close out where necessary. Provide progress reporting to the management team on current deviations when the need arises.Training Conducts training and presentations when the need arisesDocumentation 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.This 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). 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 arisesUpdate the company Electronic Document Management System with all relevant information Compile monthly progress reports when the need arises 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. Report and review temperature monitoring results post importation. Report and monitor out-of-specs; investigate and conduct a risk assessment when the need arises. Record and maintain the central data system on CAPAS and follow up until close-out when the need arises Compile and review technical quality agreements (TQA) when the need arises.Ensure current and authorized technical agreements are implemented and recorded with each supplier or third-party contractorAudits Assist with third party contractor site inspections when the need arises. Assist with preparation of reports on audit findings and follow up to close out when assisting with audits Participate and assist with local inspections on PD by the SAHPRA and/ or any other regulatory body.Standard Operating Procedures 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 Write SOPs when QA is the subject expert and GMP related SOPs when the need arises Review and update SOPs ensuring that the SOP data base is always current and valid as the need arises.Product Quality Reviews Coordinates and maintains the Product Quality Review (PQR) program when the need arises. 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 Compiles, review and maintain the related register, logs and reports. Conduct the review and compile the report when conducting reviews.Stability Coordinates and maintains the stability program and compiles, review and maintain the related register, logs and reports covering the program on Bulk material as well as Finished Packed Product and Export products when the need arises Captures all stability study data generated and compiles stability summary reportsStability Coordinates and maintains the stability program and compiles, review and maintain the related register, logs and reports covering the program on Bulk material as well as Finished Packed Product Captures all stability study data generated and compiles stability summary reportsGeneral Assist the RA department with information as and when required. Provide any budget related information as and when required. Ensure any costings provided are as accurate as practically possible. Coordinates Destructions; liaise with contractors and compile and maintain records. Coordinate and reconcile destruction requests from suppliers when required. Coordinate translations when required. Prepare and review invoices for approval. Perform any ad-hoc duties as required

Apply for this position Back to job

You must be logged in to apply for this job.

Apply

Your application has been successfully submitted.

Please fix the errors below and resubmit.

Something went wrong. Please try again later or contact us.

Personal Information

Profile

View CV

Details

Pharma Dynamics

Pharma Dynamics is a leading pharmaceutical company. We are one of South Africa's largest generic medicine providers and the country's leading provide...

{{notification.msg}}