Do you possess 5+ years Biopharmaceutical manufacturing experience within a GMP environment? If so, you could be the perfect candidate for this 12 month contract with a world class biologics client of ours in their external supply quality group.
Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.
* Manage and own NC records for External Quality
* Manage and own CAPA records for External Quality
* Manage and own Change Control records internal to External Quality
* Manage and drive Quality records to closure independently
* Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
* Doctorate degree OR
* Master's degree & 2 years of directly related experience OR
* Bachelor's degree & 4 years of directly related experience OR
* Associate's degree & 10 years of directly related experience OR
* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor's Degree in a Science Field
* cGMP Experience
* Ability to travel +/- 10% of time to domestic and international sites
Key Must haves:
This is a L5 role so they would need to be able to have previous experience
* Ability to oversee multiple projects simultaneously
* Able to successfully manage workload to timelines
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
*Trackwise is the system used onsite
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists