Assistant Manager-QA

Job Description

Key Responsibilities Overall adherence to safe practices and procedures of oneself and the teams aligned.Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards.Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.Compliance to Syngene s quality standards at all times.Hold self and their teams accountable for the achievement of safety goals.Govern and Review safety metrics from time to time.Issuance of documents, logbooks, forms and archival of relevant documents.Responsible for handling analytical QA activities related to Quality Control Microbiology & QC-Biologics.Review and approval of audit trail, trends, protocol & reports related to Environmental monitoring, water & samples.Initiation and review of QMS. Preparation & review of QMS trends Participation in investigations.Conduct audits & regular GMP rounds.Review & approval of SOP, IOP, EOP, Specifications, CSV Protocols & Qualification documents.Review & approval of routine analytical documents.Review & approval of all the documents for the adequacy with respect to the principles of ALCOA+.Review & approval of EAM, IT & relevant cross functional team documents.Review & closure of laboratory incident reports. Review & approval of Risk assessment documents. Review & approval of Method validation, Method verification, Method transfer & Method development documentsTo perform additional task as assigned by reporting manager. Key Responsibilities Overall adherence to safe practices and procedures of oneself and the teams aligned.Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards.Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self.Compliance to Syngene s quality standards at all times.Hold self and their teams accountable for the achievement of safety goals.Govern and Review safety metrics from time to time.Issuance of documents, logbooks, forms and archival of relevant documents.Responsible for handling analytical QA activities related to Quality Control Microbiology & QC-Biologics.Review and approval of audit trail, trends, protocol & reports related to Environmental monitoring, water & samples.Initiation and review of QMS. Preparation & review of QMS trends Participation in investigations.Conduct audits & regular GMP rounds.Review & approval of SOP, IOP, EOP, Specifications, CSV Protocols & Qualification documents.Review & approval of routine analytical documents.Review & approval of all the documents for the adequacy with respect to the principles of ALCOA+.Review & approval of EAM, IT & relevant cross functional team documents.Review & closure of laboratory incident reports. Review & approval of Risk assessment documents. Review & approval of Method validation, Method verification, Method transfer & Method development documentsTo perform additional task as assigned by reporting manager.,

Keyskills :
salesmisaccountstatbankingaudit traildata integrityquality controlrisk assessmentmethod transferquality standardsmethod validationcorporate culture