Subscribe

Forum

Quality/Validation/Regulatory Affairs - Portability and need?

Welcome to the newly redesigned Science Careers Forum. Please bookmark this site now for future reference. If you've previously posted to the forum, your current username and password will remain the same in the new system. If you've never posted or are new to the forum, you will need to create a new account.

The new forum is designed with some features to improve the user experience. Upgrades include:
- easy-to-read, threaded discussions
- ability to follow discussions and receive notifications of updates
- private messaging to other SC Forum members
- fully searchable database of posts
- ability to quote in your response
- basic HTML formatting available

Moderator: Dave Jensen
Advisors:   Ana, PG, Rich Lemert, Dick Woodward, Dave Walker
Meet the Moderator/Advisors

Quality/Validation/Regulatory Affairs - Portability and need?

Postby Andy R. » Thu Apr 07, 2011 7:10 pm

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.
Andy R.
 
Posts: 56
Joined: Tue Jan 10, 2012 11:31 pm

Return to Science Careers Forum

Who is online

Users browsing this forum: No registered users and 18 guests