Lead QC

Job Description

Company Name : Klin health Bio Research Pvt Ltd

Designation : QC Lead

Experience : 3-7 Years

Responsibilities :

Handling Project timelines and responsibilities for work distribution and, training ,meeting project and Method Validation timelines, coordinating with other departments.

Support QA Head for responding to regulatory or sponsor queries/audit reports/audit observations.

Support QA Head for preparation and review of QA SOP's, system SOP's of Bio Analytical SOP, Bio analytical method SOP's and Biostatistics SOP's for adequacy, correctness and completeness.

Review chromatographic data.

Plan and conduct audit of study protocol/SOP/Method validation protocol and retrospective audit of Bio-analytical raw data as well as Bio-analytical report, Method validation raw data and report and clinical report as per regulatory guidelines, in house SOP's and Protocol.

Plan and conduct in process audit of various Bio-analytical phases.

Plan and conduct system audit of various section of Bio-analytical department, General Admin, and Biostatistics department as per the schedule, prepare audit report and ensure compliance for the same.

Plan and conduct vendor audit of various vendor/ service provider as per schedule and prepare audit report and recommend to management whether vendor/ service provider qualified or not.

Train QA auditors and others on in house SOP's /system.

Review validation and calibration data of the instrument/equipment of all departments for compliance.

To prepare audit reports and forward the audit observations to respective department.

Suggesting modification in the current process to improve quality and to minimize

Interested Candidate can submit CVS's on given mail ID