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    Assistant Manager - Hyderabad, India - Masadir

    Masadir
    Masadir Hyderabad, India

    2 weeks ago

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    Description
    Dear Professionals.,

    Greetings from Masadir

    We have urgent job opening for Assistant Manager - QA - Bioassay job in well-established company at Hyderabad location.


    JOB DETAILS:

    Position:
    Assistant Manager - QA - Bioassay


    Location:
    Hyderabad, Telangana


    Salary:
    Industry Standards


    Qualification:
    Postgraduate in Biotechnology or Pharmaceutical sciences.

    Experience:
    Proven work experience (8-10 years) in Quality assurance with minimum of 3-5 years in CGMP and managing team.


    Job Description:

    Job Overview:
    Quality Assurance personnel is responsible for implementing Daicel Quality Policy and Quality Management Systems. The day-to-day work includes enforcement of quality standards and routine process checks.


    Responsibilities And Duties:

    • Responsible for leading a QA team of Bioassay and provide expertise in bioassays to the team.
    • Ensure the team's training, development, and growth.
    • Review of Bioassay method development and method validation.
    • Ensure effective implementation of Quality Policy & Objectives.
    • Review and supervise the drafting of standard operating procedures (SOPs)
    • Responsible for Compliance monitoring, and implementations of DCTI's Quality Management System, Policies and procedures in applicable areas.
    • Review of Equipment Qualification data and calibration data.
    • To handle critical quality systems like incidents, deviations, change control, CAPA, training, OOS. Participate in investigations and review of incidents, deviations, OOC, OOS, OOT and CAPA.
    • To ensure document control and data integrity in applicable areas.
    • To handle and support during the audits conducted by Regulatory bodies, statutory bodies and customers.
    • Responsible for ensuring archival and retention of all the documents and records as per the procedure.

    Qualifications:

    • Good knowledge of relevant regulatory standards and understanding of FDA, EU, ICH guidelines and regulations.
    • Ability to troubleshoot problems and communicate effectively in a scientifically sound manner.
    • Effectively collaborate across functional lines in a matrix environment.
    • Good communication skills, both verbal and written.
    • Good knowledge of Microsoft office tools like MS word, MS excel and PowerPoint.
    • Previous experience with software related to handling of documents and LIMS.
    If interested kindly share your updated cv to
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