Qualified Person - Torrent Pharma - Quality Assurance jobs in Malta - November 2024
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Qualified Person - Torrent Pharma

Konnekt

Published on 21 Aug 2023

Expired on 11 Oct 2023


Konnekt will be managing all recruitment for Torrent Pharma Malta exclusively. 

Torrent Pharma Malta,  a start-up company focusing on Pharmaceuticals and batch release testing is looking for a Qualified Person. Your roles and reasonabilities will include: 

  • Assist the QA department in the review, approval and implementation of CAPAs and Change Controls 
  • Assist in ensuring that activities carried out at the facility are compliant to EU cGMP standards 
  • Provision of Quality Assurance support on specific projects, as required 
  • Ensure that the product to be released has been manufactured and tested in compliance with its Marketing Authorization, including the supply of raw materials and packaging materials
  • Ensure that the product to be released has been stored and transported as per the required storage conditions
  • Ensure that sampling has been carried out in a manner that ensures that the sample is representative of the batch 
  • Ensure that a stability program is being implemented and adequately followed at the site of manufacture
  •  Assist in the investigation of quality defects and market complaints and is involved in the decision on whether a recall is required or not.
  • Assist in the investigation of OOS/OOT investigations 
  • Actively participate in any recall exercise as necessary, including mock recalls 
  • Ensure that the necessary technical agreements required are in place prior to batch release, and requirements laid down in such agreements are respected
  • Review and Authorize shipment under quarantine when required, based on a case-by-case basis  
  • Assist in the delivery of training to employees within the company to ensure a properly trained workforce
  • Actively participate in meetings to ensure that company processes and procedures are in line with applicable EU legislation and any update thereof 
  • Stay updated with any updates to EU GMP guidelines and legislation and attend necessary training programs, including, but not limited to those offered through TPM. 
  • Ensure that the final packaging configuration of the product is in line with the provisions of the Marketing Authorization, including registered Artwork
  • Communicate any concerns in relation to batch manufacturing, testing, storage and/or transportation with the QA department and Senior Management where applicable. 

 

 

Skill-sets and Requirements
  • Possesses excellent written and spoken communication skills in relevant languages, including English
  • Preferably a minimum of 2 years local experience within a similar role
  • Experience in managing and developing Quality Systems
Education & Experience
  • Proven license as a QP
  • Bachelors or Masters in Pharmacy
Benefits
  • Medical insurance
  • Flexible working hours

time
Full Time
Job Type
experience
Experienced (3 years +)
Experience Level
category
Quality Assurance
Category
industry
Pharmaceuticals
Industry


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