Recently a company’s HR representative contacted me regarding an “exciting” leadership opportunity in Sydney.

The phone interview went well and I was refered to “management”.  They came back and said….

“We have had some discussions with senior quality managers about your profile and unfortunately they feel your relevant experience in Sterile Micro going back 10 years is a little too long ago for us ideally.”

I then provided the following feedback.

“It is unfortunate <company name> is not interested in someone with more than the required (practical) knowledge, 10 years old or not.

I make a point of staying up to date with the regs (which have not changed much in 10 years).  I’m sure lots of people say they do.  I actually do.

• Aust GMP guidelines are based on an ICH guideline that was last updated in Nov 2000.
• PIC/s guide to GMP updated in 2015.  These are also based on the ICH guideline.
• Most of the FDA guidance documents date from before 2000.
• ISO 13408 – Aseptic processing of healthcare products – several updates up til 2015.  Here even though I’ve worked in non-sterile, processing still needed to be performed aseptically
• ISO 14698 1/2 last updated 2003 – Cleanrooms and associated control environments.
• ISO 14644 last updated 2000 – Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones.

What is senior management’s concerns regarding “no recent experience?”    I can follow in place controlled procedures,  competently conduct and report on investigations,  audit and map processes, develop and deliver training, mentor and develop teams, perform microbiological tests and gown up aseptically and everything else that ensures an unadulterated product is shipped to market after being tested in suitable facilities by trained staff in a regulatory complaint manner.”

The response to this was a canned email stating.

“We have received a large number of applications for the position and after carefully reviewing them we regret to inform you that we will not be progressing with your application at this time.  This decision was made based on other applications being more closely aligned with the requirements of the role.”

I never applied.  They approched me.

I shall convert my response to this employer into a post about the regulations and guidelines in due course.