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Quality/Validation/Regulatory Affairs - Portability and need?

PostPosted: Thu Apr 07, 2011 7:10 pm
by Andy R.
I'm an associate (MS-level) organic chemist (process chemist) who works in pharma as a process chemist. Some of the colleagues I work with are BS/MS folks who have made the jump from the bench to positions in quality assurance, validation, and regulatory affairs. I have considered such a role. Aside from my main duties, I've been exposed to such things as floor experience in a pilot plant, drafting batch records, sitting in on quality risk assessments, helping issue OOS memos, experience with change control, and basic experience/familiarity with cGMP and ICH guidelines.

My question is this - if I were able to transition into a quality/validation/regulatory affairs type of position - how "portable" is it? By that I mean applicable to industries other than big pharma or other than production of small molecule API's. I ask because many companies are shifting manufacturing and API production to CMO's or low-cost countries. I'd like a role that is more broad and "would always be there", so to speak.

Since I am an organic chemist by training, could I transition into validating a process for a biologic? Or would I be able to get into another highly regulated industry with such experience?

I'm trying to gauge the need and portability of such roles in the future. I'd like such a transition to be more "flexible", per se, than a practicing organic chemist at the bench. As many pharmas scale back their R&D, I'd hoping to get into a role that is more stable and marketable, that can build upon my experience.

Please let me know what you think - any advice is appreciated.

Thank you for your help and insight.