quality manager

assurance processes across manufacturing, packaging, warehousing, and product
release while driving a culture of quality, continuous improvement, and regulatory
excellence. Responsibilities: * Quality Management System (QMS)
o Establish, implement, and continuously improve the Quality
Management System across all manufacturing and support functions.
o Ensure compliance with regulatory agencies, and other applicable
customer specific requirements.
o Develop, review, and approve quality policies, SOPs, specifications, and
quality documentation. * Manufacturing Quality Assurance
o Ensure quality assurance oversight across raw materials, in-process
controls, finished goods, packaging, and dispatch.
o Monitor manufacturing practices to ensure compliance with approved
procedures and quality standards.
o Review and approve batch manufacturing records, batch release
documentation, and quality reports. * Regulatory Compliance & Audit Management
o Lead internal, customer, certification, and regulatory audits with action
plan compliance.
o Ensure continuous audit readiness and timely closure of audit
observations.
o Coordinate with Regulatory Affairs to maintain compliance with domestic
and international regulatory requirements.o Should have exposure to various regulatory audits (EU, USFDA, CE/MDR)
and should have successfully led the team in these audits * Risk Management & Continuous Improvement
o Lead investigations related to deviations, non-conformances, customer
complaints, CAPA, change controls, and risk assessments.
o Drive root cause analysis and implement preventive and corrective
actions.
o Promote Lean, Six Sigma, and continuous improvement initiatives to
enhance quality performance. * Product Quality & Customer Assurance
o Monitor and investigate product quality performance through
complaints, market feedback, trend analysis, and post-market
surveillance.
o Ensure timely investigation and resolution of customer quality concerns.
o Support product validations, process validations, and qualification
activities. * Supplier Quality Management
o Evaluate, qualify, and periodically audit raw material suppliers,
packaging vendors, and contract manufacturers.
o Monitor supplier quality performance and implement supplier
development initiatives.
o Ensure incoming materials meet established quality specifications. * Documentation & Data Integrity
o Maintain robust documentation systems ensuring accuracy, traceability,
and regulatory compliance.
o Ensure adherence to data integrity principles and document control
procedures.
o Monitor quality KPIs and prepare management review reports. * Team Leadership & Capability Development
o Lead, mentor, and develop the Quality Assurance team on developing
regulatory and GMP requirements.
o Conduct quality awareness and GMP training programs across the
organization.
o Foster a culture of quality ownership, compliance, and continuous
learning.

experience

20