Date: 02-Apr-2015
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please visit http://biotech.fyicenter.com/
Quality Assurance Manager in Biotech
Responsibilities will include:
· Involving yourself in the management of Quality Systems to assure GMP compliance and product quality of manufacturing activities at the suppliers for Recothrom
· The evaluation of QA Records and management of GMP Compliance, and the oversight of technical reviewers for:
o Drug Master Batch Records and executed batch records
o Compliance documents
o Disposition of Recothrom lots for clinical and commercial distribution.
· Reviewing Change Control Requests (CCR) associated with Recothrom and the coordination/tracking of CCR implementation actions
· Contributing to the Supplier (Contract Manufacturing/testing and Raw Material/Components) Qualification and oversight program, and perform supplier audits
· Collaboration with Document Control for timely document reviews and participate as a QA approver for documents such as Recothrom supplier deviation
Deliverables:
· The disposition of Recothrom lots for clinical and commercial distribution
· The successful Management of GMP Quality Systems
· Leading the audit of quality systems and the regulatory compliance status of manufacturing facilities
· Expert Supplier Quality oversight
· Generation of QA documentation such as SOPs, investigational reports Taking pride in aligning your personal purpose with a company that believes its greatest priority is to save lives
Desired skills and experience:
· A minimum of 7 years’ experience in the pharmaceutical and/or biotechnology industry
· 5+ years’ experience in pharmaceutical and recombinant protein/biologics quality organizations
· A BA or BS in a Life Science or technical area
· Proficiency in the management of GMP Quality Systems
· Expertise in working with domestic and international manufacturing sites and affiliates with respect to US FDA pharmaceutical regulations
· Proven experience in Supplier Quality oversight
· Ability to generate QA documentation such as SOPs and investigational reports
· Sound computer skills with MS Word, Excel, Power Point a nd Visio
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
