Project Impressions from a Quality PV Expert in Switzerland

Project Impressions from a Quality PV Expert in Switzerland

Last summer a Swiss pharma company called us and asked for Quality Support regarding GVP compliance after they had a challenging audit. We staffed the project with Ms. Bensalem (B) and she just finished the project after one 6 months’ extension. We are curious what she has to tell us (K): B: Many thanks to […]

Last summer a Swiss pharma company called us and asked for Quality Support regarding GVP compliance after they had a challenging audit. We staffed the project with Ms. Bensalem (B) and she just finished the project after one 6 months’ extension. We are curious what she has to tell us (K):

B: Many thanks to K-Recruiting for the one-year assignment, which I finalized this month. I enjoyed the professionalism and am very happy, that it was accomplished successfully.

K: So why did this pharma company decide to bring a freelance consultant on board and what did you help them with?

B: Well there were a lot of remediation tasks “lying around” with not enough internal resources to cover them.

And I had various areas where I supported, but in the greater sense my function was a QA Consultant in the Drug Safety Department

  • I helped with the remediation, archiving and redaction of QA documents.
  • PV training and crisis management is also a topic where I have a lot of experience and so implemented different sustainable tools.
  • Another area where I had an eye on were general developments in the field of QA operations. Here, I gave consulting input for the benefit of the QA structure. In fact, I am proud to be able to say, that the new methods I designed and implemented dramatically increased operating efficiency within the department.
  • I met regularly with the Head of QA to make sure that my learnings and knowledge are transferred to him and don’t leave the company with me after the end of the project. Sustainability is the key when you do a consultants’ job.
  • It is great to see that the know-how, learning and new developments can result in substantial savings in terms of time and money for this client.
  • As I am always looking for work, I also gave input into better management of the distribution channel and had a look at their GDP compliance and the status of necessary trainings.

K: That sounds great! Certainly there were also challenges during this time?

B: Yes of course, and I have to say the usual ones you have in projects: time-lines, multi-tasking and that you need to have maximum flexibility and proactiveness.

Another issue was that – as I was starting there after an audit – many things were not well organized. Especially the documentation for the audits. My solution: Writing down and implementing an Archiving Quality Document. Everybody welcomed it and we even nominated a designated archivist. Hopefully in the future missing documentation won’t be an issue any more!

K: How did you manage?

B: Well, I have learned that you need to be really very flexible, so I am actually used to that. One very important aspect is to listen to everybody and to make an effort in communicating really well towards the right answer. Sometimes it is as easy as picking up the phone and call the health authority to clarify conflicts regarding a QA document.

K: Thank you for sharing your experience with us! We hope to realize the next project with you really soon.

If you want to get to know Ms. Bensalem, get in touch with me:

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