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.
- 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.
- Familiarity with QC testing methods derived
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