8 Jun '21
Quality Assurance Coordinator - Cape Town

Medical, Western Cape CPT - Northern Suburbs

Market - Related

A leading pharmaceutical company based in Cape Town is seeking a Quality Assurance Coordinator to support, administer and maintain systems that ensure regulatory compliance and the quality.

Operations

Lot 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 Pharmacist
  • 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 review

Deviations 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 arises

Documentation

  • Assist with the maintenance of the contractor master documentation repository 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 documentsm(BPR), analytical methods, product specifications, stability protocols (Note that RA assists with sourcing of BMR and BPR).
  • Maintain the internal QA documentation repository 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
  • Update 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 contractor

Audits

  • 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 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 SOP’s when QA is the subject expert and GMP related SOP’s when the need arises
  • Review and update SOP’s 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 reports

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
  • Captures all stability study data generated and compiles stability summary reports

General 

  • 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.
  • Coordinate and reconcile destruction requests from suppliers when required.
  • Coordinate translations when required.
  • Prepare and review invoices for approval.
  • Coordinates Destructions; liaise with contractors and compile and maintain records.
  • Perform any ad-hoc duties as required

 PRE-REQUISITES

  • Minimum of 1-3 years work experience in a quality control, quality assurance or pharmaceutical industry
  • Document management experience
  • Experience with lot releases, PQR’s and SOP’s

Adaptability/Flexibility: (Level 2_ Tactical Lower)

  • Adjusts to work effectively within new work structures, processes, requirements, or cultures
  • Views change as opportunity to improve
  • Willing and eager to change
  • Actively seeks out positive spin-offs of change and investigates ways in which change can be used
  • Anticipates change and continuously remains prepared for change
  • Demonstrates resourcefulness in acquiring necessary knowledge, skills and competencies to adapt to change

Professional Knowledge and Skills (Level 3 _ Tactical Higher)

  • Thorough understanding of the knowledge / skill area
  • Effectively applies a broad range of principles, practices and procedures in the knowledge / skill area
  • Is sought out by others for advice for the resolution of difficult problems
  • Can work independently
  • Keeps up with current developments in area of expertise

Analytical Thinking/Problem Solving (Level 2 _Tactical Lower)

  • Appropriately derives and organises the essence of information to draw solid conclusions
  • Effectively resolves problems of a moderately complex nature
  • Synthesises data from different sources to identify trends
  • Looks beyond symptoms to uncover root causes of problems to be solved
  • Presents problem analysis and a recommended solution rather than just identifying and describing the problem itself
  • Proactively approaches others to obtain missing information
  • Takes action to reconcile discrepancies

Resilience and Tenacity: (Level 3 _Tactical Higher)

  • Tackles difficult and complex problems and takes personal responsibility and accountability for reaching solutions
  • Remains determined despite frequent obstacles
  • Maintains enthusiasm of others after disappointment or rejection
  • Bounces back very quickly
  • Leads others through dealing with disappointment/rejection
  • Re-engineers or creates new processes and systems to get around obstacles
  • Anticipates problems and proactively designs contingency plans

Quality Commitment and Work Standards: (Level 2 – Tactical Lower) 

  • Pays attention to the processes or elements leading to the accomplishment of results within own team or department, looking for ways to improve quality and efficiency
  • Examines output of own department, looking for potential improvements
  • Establishes measurements to evaluate the quality of work outputs and processes
  • Expresses concern about quality

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Ad Visible Until: 7 July 2021
Ref: CPT000155/CH

Vacancy Type: Permanent