Description
I am recruiting for an experienced Quality Assurance QA Consultant for a 12 month contract as a Quality Assurance QA CAPA Investigator- individual will asses GMP documentation, conduct gap analysis, provide insight to problems and solutions and contribute to over all process improvement. The purpose of the role is to help the client maintain compliance and prepare for inspections throughout the year.12 month contract
Quality Assurance QA Consultant- Invesitgation & CAPA
Location: Wood Cliff Lake, New Jersey
Rate: $105/hr
Job Duties:
*Tracking and trending of root cause, product impact analysis, collaboration with External Manufacturing Sites on recurring issues and CAPA identification/implementation.
*Review/Assess Investigations and CAPAs with a focus on External Manufacturing Sites
*Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies
*Manages the process for review and release of batch records and ensures cGMP requirements are met
*Leads oversight and management of all external manufacturing documents and approves
*Oversees stability program. Ensures gathering of data, out of specification investigations, summary reports are timely and compliant in regards to external manufacturing
*Preform trend analysis of root cause, product impact analysis and work with EM External Manufacturers on issues and CAPA programs
BS in Life Science or in related field
Minimum 8 years QA experience in a cGMP environment in the pharmaceutical industry
Must have prior experience in manufacturing, packaging, or testing of pharmaceutical products
Must have previous experience with External manufacturing Operations
Must have prior experience reviewing and approving GXP documents
Thorough knowledge of CFR 21, Part 210, 211, part 11
Knowledge of pharmaceutical dosage forms, injectables, solid oral dose
*Ability to write audit reports, investigations and procedure documents. STRONG analytical and technical writing skills
To find out more about Real please visit www.realstaffing.com