Quality Control Associate - Supervisor

Responsibilities

• To execute the planned laboratory activities in compliance with the cGMP and maintaining a safe work environment as per SHE norms.
• To adhere with training schedule, in completion of training requirements and method qualifications.
• To write, review of analytical method validation protocol and reports, planning and execution in compliance to regulatory norms.
• Preparation, execution and review of technology transfer of analytical methodologies.
• Ensure compliance towards quality systems and timely closure of QMS elements in the laboratory with thorough investigations
• To Initiate and close change controls for system improvements and new method/system implementation.
• To involve in compliance towards Quality Systems and timely initiation and closure of QMS elements (Deviation/OOS/OOT/incident/CAPA) in the laboratory with thorough investigations.
• To prepare or review of SOP’s, STP’s and ROA’s.
• Support for regulatory inspections and to support and plan for commercial release testing.
• Maintaining instruments along with routine calibration.

Qualifications

Educational qualification: A Bachelor’s in Chemical Engineering or a Master’s in Science

Minimum work experience: 6 to 9 years of experience in working with Biosimilar Products