AGM/DGM/GM - Quality Control (Sterile Injectables) Anthea Pharma

15.0 - 20.0 years

25 - 35 Lacs

hyderabad

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Job Summary: Responsible for leading all Quality Control (QC) activities for sterile injectable products. This includes ensuring cGMP compliance, timely testing of materials and products, method validations, and lab readiness for audits and inspections. Key Responsibilities: Oversee day-to-day QC lab operations for sterile injectables (raw materials, in-process, finished product, and stability samples). Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, EMA), and internal quality standards. Review and approve SOPs, methods (STP, GTP), specifications, protocols, and validation/transfer documents. Manage method validation, verification, and transfers for drug substances, products...

Posted 3 weeks ago

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Senior Executive / Assistant Manager - Regulatory Affairs Anthea Pharma

5.0 - 10.0 years

5 - 9 Lacs

hyderabad

Work from Office

Job description Experience & Skills required: Experience in new development / product life cycle management associated with regulatory function. Well versed with product development / Manufacturing and sterility assurance, deficiency management. Well versed with labelling requirements. Well versed with eCTD operations. Experience in handling drug device combination products. Good written and verbal communication. Markets: US / EU - Majorly. Experience required: 5-9 yrs in sterile formulations - US market. Qualification: M.Pharmacy

Posted 2 months ago

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