Develop and implement standard operating procedures (SOPs) and quality management Systems (QMS) using ISO 13485/21/CFR part 820, cGMP compliance and other regulatory standards.
Develop Process Flow diagram (PFD), Process Failure Mode Effect Analysis (PFMEA) and Quality control plans.
Execute validation activities for IQ/OQ/PQ/TQ.
Prepare Non-conformance Material Reports (NCMR).
Skills Required:
Master’s degree in Science, Technology, Computer Applications or Engineering (any) is required.