QA Complaints Specialists 09/22

QA Complaints Specialists (Newtown, PA) – Develop and implement regulatory compliance strategies for the company’s research, development, and manufacture of generic pharmaceutical products applying ANDA 21 CFR Part 210 and 211; Review/Issuance of Master Batch Records and qualification Protocols (IQ/OP/PQ) in compliance with cGMP/FDA/OSHA/EPA/DEA regulations and standard design; Develop, review, and implement drug complaint investigation activities applying GDP and ICH; Prepare and review Annual Product Quality Review Reports; Prepare and facilitate submission of Field Alert Reports (FAR)/Product Recalls; Initiate/Review and track GMP compliance and approval of Deviations, Change Controls and CAPA for production processes, facilities, and equipments; Compile and review QMS data for quarterly Quality Council presentations; Participate in FDA regulatory audits. Must have a Master’s Degree in Chemistry, Pharmaceutical Science, or Pharmaceutical Technology plus skills and knowledge of CAPA, Change Control, Regulatory Audits, 21 CFR, GDP, ICH, IQ/OQ/PQ, ANDA. Job location: Newtown, PA. Submit résumé referencing job code ANS011 to HR, KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940.

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.