Manager Quality Control

☞ Abbott

看过: 101

更新日: 30-05-2024

位置: Baddi Himachal Pradesh

类别: 质量保证/质量控制

行业: Hospitals Health Care

水平: Associate

工作类型: Full-time

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工作内容

Experience Required: B.Pharm / M. Sc. with 12-15 years of experience in experience in Chemical & Instrumental analysis QC (GLP).

Approved chemistlicensed candidate shall be preferred.

Well versed with CAPA, GMP documentation, should have exposure to regulatory audits such as MHRA, USFDA etc.

Followings Will Be The Responsibilities Of The Position Holder
  • To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements and monitor compliance of Hormone block QC.
  • To ensure that documents are updated and amended as per new pharmacopoeias and regulatory guidelines.
  • To monitor the maintenance of GLP activities in all the sections of the lab w.r.t current regulations.
  • To monitor data integrity and laboratory compliance in the quality control department.
  • To ensure the maintenance/ Calibration and approval of all instruments/equipment’s in Hormone block QC.
  • To ensure the maintenance and approval of all working standards, Reference standards, Primary standards and volumetric solutions in Hormone block QC.
  • To ensure analysis of In-process, SFG/ FG, stability Samples.
  • To ensure sampling and analysis of Raw Materials and Packing materials.
  • Facing internal audits and External audits and ensuring compliance.
  • On job training as necessary to develop skills and improve productivity.
  • Maintenance of documents related to Quality Control of Hormone block.
  • Qualification of Instrument.
  • Analysis of additional samples for laboratory investigation.
  • Co-ordinate for AMC for equipment and keep record of maintenance of equipment.
  • Analytical Method Validation/Analytical Cleaning Method Validation as and when required.
  • Training of new persons as per procedure and requirements.
  • Maintenance/ Calibration and review of all instruments and equipment’s in QC.
  • To ensure the safety compliance in quality control department.
  • Ensuring audit trail review.
  • Carrying out OOS / OOT and Incident investigation.
  • Coordinating and aligning the practices and procedures in line with the COBC requirements.
  • Implementing all document in the Lab related to ISO/IEC 17025
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最后期限: 14-07-2024

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