James Egan Email & Phone Number

Morris Plains, New Jersey, United States

Provide Quality leadership and oversight on the shop floor in support of manufacturing operations.

Morris Plains, New Jersey, United States

Supported the progression and closure of overdue CAPAs stemming from process deviations, audit observations and continuous improvement initiatives. Executed effectiveness checks.

Parsippany, Nj

Provide quality assurance support to R&D project teams in all aspects of the product development and technical transfer processes. Negotiated and managed quality agreements with contractors prior to commencing GMP activities, led product quality investigations to identify root cause and ensured appropriate CAPA was implemented.Led an R&D project team through the later stages of development of a fast dissolving cold & flu tablet and managed the analytical test method validation and tech transfer processes from contract sites into GSK.- Conducted self assessment audits- Contributed to CMC section construction and addressed subsequent questions from regulatory authorities relating to medicinal gums & strips and solid dosage forms.- Evaluated and approved change control requests, OOS investigations, deviations & CAPA in TrackWise.- Conducted gap analysis against global quality policies, ensuring local R&D SOPs were in compliance with parent corporate procedures.- Batch record construction, pre & post review and approval.- Author and approve SOP and Work Instructions.- Equipment qualification- Cleaning verification / validation

Parsippany, Nj

Developed, validated and transferred various HPLC, GC and potentiometric methods for cold & flu tablets, medicinal mouthwashes and toothpastes. Managed the analytical instrumentation calibration and maintenance program for the R&D business support group.Hired, trained and supervised several temporary analysts through methods validation and stability testing to build product dossiers for European toothpaste and mouthwash product compliance.