FDA VAlidation Analyst in NJ Location : Somerset, NJ
Duration : 6 Months + Rate : open Rate : Open ? FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. Also: The roles of different V&V protocols; How to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources (personnel, budgets, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 are considered. ? Verification or Validation -- Recent regulatory expectations. ? The Master Validation Plan. ? Product Validation - how it differs from Process / Equipment V&V. ? Process / Equipment / Facility Validation. ? When and How to use DQ, IQ, OQ, PQ. ? How to use your Risk Management Tools (per ISO 14971) - expand or contract the validation templates. ? The 11 "must have" elements of software validation. ? "White box" and/or "black box" and some test case suggestions *Includes is the requirement please send me matching resumes along with the below details. * ** *Full Name: Rate: Availability: Current location: Visa Status: Contact #: Email: Employer Details : F2F at own expenses(Yes/No) : Best time to call : Willing to relocate* ** *Kindly share the requirement with your resources before send their resumes..* *Regards SAM Tel : 732-637-0815 Fax: 253-830-7224 Email : sa...@harriersys.com Harrier Infotech USA Inc. http://www.harriersys.com* -- Thanks and Regards Sam B Tel : 732-637-0815 Fax: 253-830-7224 Email : sa...@harriersys.com Harrier Infotech USA Inc. 9 Westlake Court, North Bruswick, NJ 08902 http://www.harriersys.com sam.harriersys : gtalk sam.harriersys : Yahoo IM
