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.
Post: Regulatory Affairs - Sr. Executive/ Executive, Production -Operator/ Executive:, QA - Validations - Sr. Executive/ Executive:
hiring for the below positions for Injectables
Regulatory Affairs
Sr. Executive/ Executive: B Pharm / M Pharm with 4 - 6 Years experience in Regulatory Affairs for US Market
• Responsible for the preparation and meticulous review of all pertaining technical documents required for USFDA filings especially Module- 2,3 in e-CTD format for CVM.
• Responsible for preparation and review of Batch production control records, stability protocols, submission protocols, Submission batch summary reports, stability data and stability reports for ANDA submission batches.
• Responsible for Support regulatory affairs activities in ANDA filings
• Responsible to support technical data for ANDA filings and Responsible for support to address responses for query from customers and regulatory agency.
• Responsible for review of change controls and deviations and their assessments required for submission batches and to address the responses from customers and regulatory agency.
• Coordinate with concerned departments like Quality Control, Quality Assurance, Manufacturing and Research Development for compilation of technical data for dossiers and meet the submission timelines.
• Review of Technical documents Like Product development report, APR, API Tech packages/DMFs,
• Responsible for preparation and review of Post approval stability protocols and annual report and its supplements.
• Review of documents like API, In-Process, Finished Product and Excipients and packing material specifications and STPs.
• Review of documents like process validation protocols and reports.
• Review of stability study protocols and reports (Longterm, Intermediate, Accelerated).
Production
Operator: B.Sc / Diploma with3 - 4 Years experience in operating vial filling, GMP&GDP, and area cleaning.
Executive: B.Pharm / M.Pharm with 3-5 Years experience in Compounding activities in Injectables, should have knowledge on CIP &SIP studies, Vail Filling & Sealing,filter integrity.
Asst. Manager: B Pharm / M Pharm with 8-10 Years experience, should be able to planning & execution of total line activity.
QA - Validations
Sr. Executive/Executive :B.Pharm/ M.Pharm with 4- 7 Years experience in validation of sterile injectables.
Protocols preparation of equipment's and utilities IQ, OQ, PQ, RQ etc.
Execution of installation qualification, operational qualification, performance qualification and requalification. Compilation and summary preparation of validations.
Utilities and equipment's HVAC, vial filling, washing, Tunnel, Autoclave, sealing, terminal sterilization etc. Temperature mapping of area and stability chambers Preparation & Tracking of validation schedule.
Aseptic process simulations Visual inspections
Candidates having only injectable experience share your profiles to
Mail ID: - planthr@cronuspharma.com
Work Location : Cronus Pharma Specialities India Pvt Ltd, GMR Hyderabad Aviation SEZ, MamidipaUy(V), Balapur(M), RR(D), Telangana-81.
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