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    Manager Quality Control - Ahmedabad, India - Biotech Healthcare

    Biotech Healthcare
    Biotech Healthcare Ahmedabad, India

    1 week ago

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    Description

    Role Objective:

    A key objective of this role is to oversee and ensure the implementation of Good Practices within the Quality Control Department. They will be responsible for maintaining standard operating procedures (SOPs), conducting testing in adherence to written procedures and managing the analysis of various samples. Additionally, they will play a crucial role in method validation, calibration of instruments, training of personnel, and ensuring compliance with regulatory standards.

    Desired Candidate Profile:

    • Bachelor's or master's degree in Organic Chemistry or Biochemistry, with a focus on analytical chemistry with minimum 10 years of experience in pharmaceutical Quality Control, with expertise on comprehensive understanding of analytical instrumentation and Good Manufacturing Practices (GMP).
    • Strong problem-solving abilities, excellent communication skills, and the capacity to work independently under pressure are essential qualities for this role.

    Role Requirements:

    • Develop and maintain Good Practices within the Quality Control Department.
    • Prepare, review, and enforce Standard Operating Procedures (SOPs) for testing and analysis.
    • Ensure all testing is conducted in accordance with written procedures and compendial methods.
    • Create a daily sample analysis plan and oversee its execution.
    • Perform sampling, analysis, and reporting of various samples including raw materials, finished products, and intermediates.
    • Conduct destruction of leftover sample quantities after analysis completion.
    • Execute Analytical Method Transfer (AMT) and Analytical Method Validation & Verification (AMV).
    • Prepare working standards and reference standards, ensuring their availability and qualification.
    • Conduct analyst qualification and provide on-the-job training to new QC personnel.
    • Record raw data and analytical results accurately and appropriately.
    • Report any abnormalities, out-of-specification results, or deviations to the appropriate authorities and follow the necessary procedures for investigation.
    • Maintain calibration of laboratory instruments and prepare master calibration and preventive maintenance plans.
    • Review and prepare Stability Study Protocols/Reports, Hold Time Study Protocols/Reports, and Qualification Protocols/Reports.
    • Manage stability chambers, sample loading, and analyze stability and hold time study samples.
    • Ensure compliance with lab observations and review analytical data for adequacy and integrity.
    • Establish a system for releasing or rejecting raw materials, intermediates, and packaging materials.
    • Qualify all software and applications, including participation in IQ, OQ, and PQ activities.
    • Ensure timely submission of analytical data to QA for batch release.
    • Troubleshoot analytical method and instrumentation issues.
    • Assist in the review of team data and provide necessary guidance and support.

    Functional Skills:

    • Thorough knowledge of analytical instrumentation.
    • Comprehensive understanding of Good Manufacturing Practices (GMP).
    • Proficiency in method validation and analytical techniques.
    • Strong organizational and planning skills.
    • Excellent written, verbal, and interpersonal communication skills.
    • Demonstrated ability to work independently and efficiently manage multiple deadlines.

    Behavioral Skills Required:

    • Strong problem-solving abilities.
    • Effective leadership and team management skills.
    • Attention to detail and accuracy in work.
    • Adaptability to changing priorities and environments.
    • Commitment to quality and compliance standards.

    Team Size to be Manage:

    • Responsible for managing a team comprising 5 to 6 members, with the position reporting directly to the General Manager - Quality Control.

    Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.

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