Cronus Pharma is a fast-growing, privately held veterinary pharmaceutical company located in New Jersey, dedicated to providing innovative and cost effective products to the animal health market. Our team of seasoned industry professionals have been intimately involved in the establishment, and growth of several pharmaceutical manufacturing, and distribution firms in both the human and animal health pharmaceutical industries.
Post : Sr. Executive / Executive levels on priority
Injectable Formulation - AQA (Chemical)
Job Description
• Review of Protocols and reports related to Analytical method validation/Verification of API and Finished product, Vendor qualification, cleaning validations. Hypothesis analysis, general validations, Stability, photo stability, thermal cycling, in use, split study and miscellaneous studies and approval in LIAAS where ever applicable.
• Review of raw data and electronic data for the in process samples, finished samples, hold time samples, process validation samples, stability, additional stability studies samples, water samples, cleaning validation samples, raw materials, packing materials, analytical method validations and verification samples, RLD related samples, general protocol and hypothesis protocol based study data, analyst qualification data, trending of water samples and miscellaneous study samples and approval in LIAAS where ever applicable.
• Review of audit trails and chromatographic data for empower systems, data for standalone systems.
• Review of laboratory instrument calibrations, qualifications, preventive maintenances, specifications, STPs and SOPs and approval in LIAAS where ever applicable.
• Approval of specification IDs, work sheets, test, test plans, and reserve samples in LIAAS.
• Review of investigations related to laboratory incidents, out of tends and out of specification results.
• Allotment of numbering for incidents, OOT and OOS results, preparation of event classification form, preparation of laboratory trends for incidents, OOS and OOT for each quarter for QRAA.
• Monitoring of laboratory activities and ensuring for compliance and participating in laboratory investigations.
• Preparation & review of sops & STPs
• Withdrawal of stability samples, maintenance of stability chambers, handling of alarms, review and approval of stability compilations.
• Participating in external laboratory evaluations.
Experience : 5 to 8 years
Walk in Interview
Date : 11th August - 2024
Time : 09:30 AM to 4:00 PM
Venue : Cronus Pharma Specialties India Pvt Ltd,
Plot No: 1-98/5/78, Jubilee Enclave,
Madhapur, Hitech City, R R (D),
Hyderabad, Telangana - 500081
Send your CV to : hr@Cronuspharma.com / planthr@cronuspharma.com
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