Walk-in Interview for QA positions in API pharma
Location: Global Calcium Pvt Ltd. Hosur (SIPCOT I)
Date: 5th March 2022 (SAT) Time: 9 am to 12 noon
Quality Assurance Jobs
Designation: Senior Executive / Asst Manager
Experience: 4 to 7 years
Qualification: MSc Chemistry / B Tech Chem Engg
Experience in API Quality Compliance, data integrity, audit trail review, batch record review, records pertaining to process validation, cleaning validation, equipment qualification.
Experience in facing regulatory inspections (USFDA, EDQM, COFEPRIS etc.)
Responsible for Preparation of Master Formula Record/ Lot Manufacturing Record/Process Validation Protocol/ Reports.
Perform Risk assessments for process, impurities management and facilities.
Responsible for documentation of Shop floor manufacturing records and related documents.
Basic Knowledge on fixing Critical control checks, In process and Intermediate checks and specifications.
Knowledge on Process Development Report / Technology Transfer documents, documents review and to support regulatory filings.
Must have faced atleast one regulatory audit (preferrably USFDA)
Good in Report writing and Document Review – Demonstrate ownership and speed in execution
Male candidates preferred