Sr. Quality Associate - Engineering Compliance Kemwell Biopharma
Kemwell Biopharma
Office Location
Full Time
Experience: 6 - 6 years required
Pay:
Salary Information not included
Type: Full Time
Location: Karnataka
Skills: Calibration, PM, Breakdown Maintenance, Utility Operation, Surveillance, Compliance, SOPs, Deviations, CAPA, QRM, Documentation check, technical areas, Process areas, Maintenance of Equipment, building infrastructure, Workorder review, Quality perspective, Calibration certificates, Calibration Activities, Engineering design documents, Preventive Maintenance checklists, Calibration procedures, IT Procedures, QMS elements, Change Controls, Audit commitments
About Kemwell Biopharma
Job Description
Roles & Responsibilities Review of engineering activities like calibration, PM, breakdown maintenance, utility (clean & black) operation by means of documentation check & surveillance of technical and process areas to ensure compliance to written procedure on maintenance of equipment, utilities and building infrastructure. Participate in routine equipment breakdown workorder review meetings with CFTs, review and assess workorder reports from quality perspective. Ensure & support its timely closure. Support annual review of breakdown of equipment, utilities & facilities and participate in remediation program. Review Calibration certificates of instrument installed in plant and participant in calibration activities conducted on shopfloor. Support review of Engineering design documents related to Equipment/Utilities as an SME Review SOPs, Preventive Maintenance checklists, Calibration procedures, IT procedures implemented at site. Extend support to Engineering & IT department by tracking, drafting, reviewing & closing documents related to QMS elements like Deviations, Change Controls, CAPA, QRM, audit commitments etc. Qualification: BE/B.Tech (specialization in Mechanical or EEE), B. Pharm Experience: >6-8 Year (Preferably in Biopharma),