Opening for Sr exe / Asst Manager -QA in NAARI - 6 posts
NAARI aspires to be a world leader in the area of female healthcare, providing medical solutions from puberty to menopause. Our aim is to be the world’s first 100% integrated generic female health pharmaceutical company. This implies complete involvement in every step of production, going from plant extract to final dosage forms. By giving our stake holders cutting edge expertise, we set the standard for female health products, globally.
Post: Sr exe / Asst Manager -QA
• SOP review and development for system and process
• Responsible for compliance to various cGMP guidelines including national and international guidelines for formulation facility (Tablets, Capsules)
• Handling of regulatory and customer audits. Self- inspection (internal audit) once in a six month and or in case of re-call
• Vendor audit in case of material rejection or market complaint and maintain the audit report as well as compliance report follow up.
• Training to the employees regarding SOPs, Current GMP, ICH guideline and ISO guideline for environment monitoring.
• Periodic review, development, revision and approval of validation mater plan. Review and approval of Validation/ Qualification documents
• Review of ANDA document like filled exhibit batch record, intended BMR\BPR, specification and STP. Co-ordination with IRA and cross functional team for document submission to regulatory bodies (ANDA).
• CAPA management from internal / external failure, market complaint & deviation. Investigation of OOS, OOT and failure investigation.
• The person must have at least 3 years of experience for Executive Profile and have atleast 6 years of experience of working in Regulatory Plant for Asst. Manager Profile.
• Must have knowledge about all the function of Quality Assurance
• Must have knowledge about the exhibit batches for US/ Europe and filing of ANDA
• Must have faced regulatory audits like USFDA, MHRA, TGA, WHO - Geneva, ANVISA etc.
Note : This Job is for Rudrapur Location for our Formulation Plant.
Experience: 5-10 Years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
End Date: 30th March, 2012
Applications after end date will not be entertained.
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