Assistant General Manager-QA

Job Description

Handling of manufacturing quality assurance of Chemical development, Analytical Quality Assurance activities related to Stability center, Chemical development and client-dedicated centers.Responsible for tracking and compliance of quality activities related to delivery of Chemical development to meet 100% business requirements and ensure no loss of delivery due to quality.Participate in technical discussion with cross functional team and clients for QMS (OOS, OOT, Deviation, and Complaint Investigation/CCF) and provide timely decision for closure of QMS in line with quality agreement and GMP requirements. Approve the investigation and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA. Closure of Deviation. Approve the extension request as applicable ensure control measures if Deviation unable to close within the specified timeline.Approve of CAPA. Closure of CAPA. Guide the respective personnel on proposal and implementation of CAPA, approve of extension request as applicable and ensure control measures if CAPA unable to close within the specified timeline.Approve and closure of change control. Approve of extension request if change control unable to close within the specified timeline.Approve the investigation and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA. Closure of OOS. Approve the extension request as applicable ensure control measures if OOS/OOT unable to close within the specified timeline. Approve the investigation and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA. Closure of laboratory incident. Approve the extension request as applicable ensure control measures if laboratory incident unable to close within the specified timeline.Tracking of QMS of chemical development and analytical QMS of all laboratories on regular basis and guide/support team for timely closure. Take pro-active actions to improve compliance level.Participate in all management review of Chemical development and analytical laboratories and ensure all quality related matters are presented in line with SOP and significant quality matters are highlighted, discussed and identified actions are tracked for closure.Trending of QMS and audit observations on quarterly basis of rolling previous annual data to identify root causes for QMS events of repeat errors and ensure adequate CAPA are initiated and tracked for ensure timely closure. Monitor the identified gaps having the adequate control measures and appropriate actions has been taken and train the employees on the regulatory update.Monitor the vendor Qualification and ensure the periodic qualification taking place timely.Review and approval of SOPs, specifications, protocol and reports schedules and other related documents as applicable.Approve the Quality agreement and responsible for clauses. Approve the CSV related documents.Prepare annual budget and ensure department operation within the specified budget.Prepare and communicate MIS reports with management and stakeholders.Responsible to Review and approval of Analytical and Cleaning Method validation, Process validation, Excel validations, Forced degradations - protocols and reports.Govern and Review safety metrics from time to timeClient ManagementTo communicate with key clients and ensures all requirements are met. Identify point of dissatisfaction and take pro-active actions to avoid escalations. Participate in all regular Q-Q calls with Major clients Chemical development and ensure quality decisions are made in line with quality agreement, Syngene SOP, GMP and regulatory requirements.Monitoring of iteration in documents with client and take adequate actions on trending of gaps identified during review for meeting client expectation to zero escalation from client. Audit managementTo lead all Regulatory and Client quality Audits of CD and stability and ensure to meet KPI of no Major and Critical observation.Ensure internal and external audit observations are responded with adequate CAPA on timely manner and Tracking of Audit CAPA for timely closure.Effective implementation of self-inspection program to ensure zero observation in the internal and external audits.Monitor the timely response of compliance to the audit observation and train the employees on learning form the audit.Compliance and simplificationWork closely with all quality control and manufacturing heads for simplification of processes and present outcome to management in measurable formProvide technical guidance to quality control and manufacturing leads for compliance and delivery requirements.Identify and implement process changes for improvement in compliance and efficiency. Improvement in efficiency of QA reviews, set Key Performance Indicators and monitor regularly for improvement.Monitor Training compliance of QA and analytical QA team. Imparting training on QMS systems, Investigations, GMP, data integrity and good documentation practice.Provide training to the related employee on the compliance issues and establish measures to prevent noncompliance from GMP, GDP, GLP, safety policy, procedures, and stated requirementsProvide training to the related employee on the compliance issues and establish measures to prevent noncompliance from Data Integrity policy, SOP and approved instructions. Educational Qualification: M.Sc. , with minimum 15 years of working experience with API QA or CQA in a grade A pharma company/ Life science. Technical/functional Skills: Good in technical and communication skill. Exposure to regulatory inspections Experience: 15 to 20 years Behavioral Skills:
• Should be an adaptive learner.
• Should demonstrate effective Communication skills
• Organization and able to balance work and Life
• Should possess good Time Management abilities.
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Keyskills :
salesbusiness developmentmanagementmarketingtargetkey performance indicatorscontinuous improvement facilitationroot causequality audit