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BriefCase

Assistant Manager - Quality Assurance Job in Centrient Pharmaceuticals

Assistant Manager - Quality Assurance

Centrient Pharmaceuticals 4+ weeks ago
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Job Summary

Description

Position Description :

To ensure the compliance of quality system requirements and applicable pharmacopoeias as well as cGMP/GLP/ICH/USFDA and other applicable regulated guidelines.

Key Responsibilities:

  • To ensure that activities carried out at the site are meeting the GMP / GLP /ICH requirements and that the guidelines are being followed. To also ensure that only properly trained personnel are involved in the storage/production / quarantining and analysis of a product.
  • To ensure that only qualified instruments and equipment are used for the manufacturing, testing and storage of the products.
  • To ensure any process failure / OOS/complaints are properly investigated and CAPA was taken.
  • To ensure the compliance improvement plan is routinely updated and the actions are taken as per the CAPA suggested. Also, to monitor that the actions taken are routinely followed and becomes part of the system.
  • To ensure that the compliance improvement plan originating from different internal/external audits, CAPA from deviations and complaints are closed properly and practised regularly.
  • To ensure the product is produced in a way that the quality is assured and GMP is in compliance all the time.


    • Requirements

    • Post-Graduation in Chemistry.
  • having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines, ICH guidelines.
  • Knowledge on qualification and validation for lab instruments and plant equipment.
  • Well-versed with statistical techniques for analytical data evaluation & Quality Risk Assessment.
  • Minimum 14 years of experience in Pharmaceutical industry and extensive Quality Assurance experience in API manufacturing industry.
    •
    Experience Required :

    Fresher

    Vacancy :

    2 - 4 Hires

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