Overcoming Remediation Challenges
India is a burgeoning market for us at Quanta, and we relish the opportunity to work in the large, diverse industry that exists in the bustling country. Such opportunity came up at a similar time for two separate organisations who both had the same issue. Both companies had sterile fill finish manufacturing facilities based in India, and both had received an FDA warning letter informing them that they were no longer allowed to manufacture their drugs due to quality issues in the manufacturing facility. Whilst this is obviously a significant issue for any manufacturing facility, it is one that can be overturned by focusing on the remediation of the site.
We were approached by each of the organisations due to previous working relationships we had formed with hiring directors and our reputation within the industry. Quanta were tasked with supplying a team of quality specialists to aid, support and direct the remediation activities on-site.
Along with our reputation within the international QA remediation market, our ability to offer compliant solutions for our clients and candidates meant we could provide peace of mind to both organisations during the sourcing process. We’ve also built up an extensive pool of quality contractors, many of whom have previous global experience with FDA regulations, had prior experience of working in India and spoke some of the country’s 22 recognised languages. Both projects involved site-wide remediation processes with a focus on QA, and we could source skilled, qualified consultants who had the relevant experience required to tackle this task.
After completing pre-screening for possible candidates, we submitted only fully qualified profiles for our clients to review. We then arranged interviews according to time differences with managers, which resulted in Quanta placing eighteen contractors with one client and nine with the other. All of our contractors came from Europe, highlighting the strength of our compliance processes and our international mobilisation assistance. As a result, we have two very happy clients who can now continue manufacturing.
While the projects have undoubtedly been a success, we did have to overcome some challenges when it came to placing European contractors in India. Mobilisation always plays a part, and our consultants worked hard to ensure all transport, accommodation, visas and immunisations were taken care of. We could also offer an attractive package for our contractors, plus the added benefit of being able to travel around India and surrounding countries easily. What’s more, such a big project with an FDA focus is a huge draw for those working in QA remediation, with a fast-paced, challenging and interesting work dynamic.
Our work with one of the clients was so successful that we ended up being their sole supplier with contractors on the ground – when we started working with them, Quanta were one of four suppliers providing contractors for remediation. After becoming their chosen provider on site, we are looking to continue a long and happy working relationship with them.
To find out more about how we can support you, contact the team today.
Newly built Biopharmaceutical manufacturing facility has a contract requirement for an experienced Lab Validation Engineer to generate, review & approve the IOPQ protocols and validation documents
Republic of Ireland
QA Validation Consultant Technical Writer Ireland is a hive of activity for the Life Sciences Industry at present with no shortage of major expansion/ new build facilities. We have an exciting
Technical Specialist - Validation - Global Pharmaceutical Company - County Cork - 11 month contract One of our Pharmaceutical clients - a global healthcare leader - is looking for two Technical
QAV Specialist required for a world Leading bio tech organisation who are at a peak phase in establishing an innovative and industry leading manufacturing facility in Dublin, Ireland, just 20 minutes
Do you relish the opportunity to work with a leading UK based Biologics manufacturer? If yes, then this is the assignment for you! Our biotech client with manufacturing facilities just outside