Job Responsibilities
Major esponsibilities are to establish quality systems for the
device part and for drug clinical supplies. Since we are a start
up company Iam involved in the clinical studies, in the
production and release of clinical supplies. As in most sturt up
I will contribute in every field that it looks that need
orgenizing. Time 50% clinical , the 25% QA ,mainly focusing on
design control.25% regulatory,preparation the device for
obtaining CE mark in europe
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Job Requirements
Igoy PHD IN BIOCHEMISTRY, post doc in NIH,got a sinior lecturer
degree in university and than left to the Industry. Their was
need regulatory person and QA and by the aid of an experience
consultor Ilearned the proffesion. I non something that you can
learn it at school ,one must got experienced
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Uppers
That Iam involved in a lot of field and can influence the company
directions.That Iam continuing learing all the time and also invoved in the
development.In general, QA is improving, lot of interactions with all the
departments so by beeing exposed to every thing that is going on you one gets a
lot of knowkedge
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Downers
Alot of pressure if you are invoved with production, always
their is a debate how much QA, TO RELEASE OR NOT A BATCH,a lot
of money is involved in such a decision and of course the CEO
pessure to release lots that are out of spec. Sometime to be the
policeman pf the company
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Lifestyle
Work hours are very long, at least 12 hours a day. As bieing responsible for
clinical, it involves a lot of buisness travels.Company social events once a year
and there is no special code dress, also you canot dress like an hipi
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Compensation
Copensation i high, a car is part of compensation, we have
options and social bennefits
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Advice to Jobseekers
Be very orgenized, be prepared to be sometimes outsider since
sometimes QA is not the most important position unless you are
in a drug company, knows how to get work done by other
departments, a lot of patients during implementation
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