What are the responsibilities and job description for the Quality Control Analyst position at TekOne IT Services Pvt. Ltd.?
Execute routine and non-routine testing to support manufacturing, validation, and development studies, including drug substance and drug product samples, stability testing, and various protocol studies.
Maintain GMP compliance and operational readiness of QC areas, ensuring adherence to industry standards.
Manage critical reagent inventory, including antibodies and cell banks, ensuring appropriate quantities are available for testing.
Assist in sampling activities for various studies and manufacturing processes.
Participate in complex projects, operational excellence initiatives, and quality systems improvements.
Collaborate with team members to meet objectives and schedules, and provide recommendations for process improvements.
Prepare and review documentation, ensuring all QC testing activities are in compliance with regulatory and internal standards.
Required Skills And Qualifications
Complete understanding and application of industry principles, concepts, practices, and standards.
Knowledge of GMP and pharmaceutical industry best practices.
Strong critical thinking and problem-solving skills.
Experience in laboratory operations, testing methods, and maintaining reagent inventories.
Ability to work independently with general supervision and meet established goals.
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