Quality Control Associate - Supervisor

Location: Hyderabad

Job Description
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
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

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.

Requirements

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