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The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

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Position: Sr Manager Quality Control

Location: Ahmedabad, Gujarat

JOB DESCRIPTION:

  • To develop, ensure, implement, and maintain a GxP compliant Laboratory systems.
  • To ensure training and effective implementation of current Good Laboratory Practices.
  • To establish and ensure analysis, approval/rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In — house method for Oral Dosages and LVP facility.
  • To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done.
  • To Ensure the Maintenance of the Department, Premises, and Equipment.
  • To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved specifications and applicable guidelines.
  • To ensure that the specifications and the testing methods are in line with the latest guidelines and applicable pharmacopeias.
  • To approve specifications, sampling instructions, test methods & other Quality control procedures for the oral and liquid injectable facility.

  • To approve and monitor all contract analysis.
  • Ensure the required initial and continuing training of Quality Control personnel is carried out and adapted as per requirement.
  • To assist in the investigations related to the laboratory, product failure, incidents and Risk assessments.
  • Review and disposition of the nonconforming materials in co-ordination with Quality Assurance.
  • To ensure the compliance of the Quality Management System and CAPA effectiveness related to the Laboratory.
  • To apply total quality management tools and approaches to analytical and reporting processes.
  • Create and direct environmental monitoring programs in line with regulatory requirements.
  • To continuously review quality control processes, procedures, and capabilities in order to sustain the most cost-effective and efficient methods for meeting quality requirements and making recommendations for improvement as appropriate.
  • To monitor and report quality control progress, notify any discrepancies or potential concerns to the site Quality Head.

  • Support the development of quality goals and targets as part of the organization’s strategic plan.
  • Maintain an active role in internal continuous improvement initiatives.
  • Design, develop and implement quality control training programs.
  • To ensure the self-training in the ISO train within the stipulated time frame. Business Administrator for Darius System, to ensure the review and approval of documents in Darius.
  • To be responsible for the Laboratory Quality management system and internal Audit as per NABL ISO/IEC 17025.
  • In absence of the position holder, the Manager/ Group manager working in the respective section or shall be responsible for day to day working.

Work Location: Village Mauza: Baddi

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