QA Specialist
Gulf Pharmaceuticals (JULPHAR)
Total years of experience :17 years, 4 Months
Experience in preparing documents for regulatory filling of products.
Adequate knowledge and experience (from last 9 years) in managing the Handling and execution of several Qualification and Validation activities related to Facility, Utility, Equipment, Process, Cleaning and Sterility Assurance Validations.
Quality Management systems (QRM, Change control, Deviation, Complaints, OOS, CAPA, Recall and returns management, Product quality review, Training, Document management).
Hands on experience in preparing audit compliance reports for regulatory inspections and customer inspection observations.
looked after all the Plant compliance \[Plant Regulatory\] activity related to review, compilation and closing of Process Validation protocols, quality control documents, batch records related to submission batches for US, Ph.Eur and INVISA and sending it to corporate regulatory affairs department to be submitted to regulatory agency
Validation, Qualification activities in sterile plant
IPQA and RA
IPQA