Krishna Dhas

QA Manager

Talent

Coimbatore SouthMember since November 9, 2026

GMPEUGMPWHO GMPUSFDAChange controlRisk AssessmentTabletsDry syrupCleaning validationProcess validationEquipment validationcheck sheetflow chartsfishbone diagrams

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GMPEUGMPWHO GMPUSFDAChange control

About

Result-oriented QA Manager in pharmaceutical manufacturing, specializing in GMP, EUGMP & USFDA regulatory compliance, validation, and quality management systems. Proven ability to lead cross-functional teams, handle audits and ensure continuous improvement of quality processes. Skilled in documentation, CAPA, change control, and risk management.

Experience

QA Manager - East West Pharma - Raipur, Uttarakhand

(2018-10)

Lead a QA team in a cGMP-compliant manufacturing facility, ensuring product quality and regulatory compliance.
Oversaw the implementation and maintenance of QMS, including document control, deviation, CAPA, and change control systems.
Coordinated and faced multiple regulatory inspections and customer audits successfully.
Managed product complaints, market recalls, and risk assessments.
Planning & supervision of tablets, Dry syrup, Softgel manufacturing & check in-process parameter at regular.
Supported QA leadership in batch record review, product release, and deviation handling
Trouble shooting and problem solving on spot. Implement of productivity.
Prepared the cleaning validation
Conducted in-process checks and audits for manufacturing and packaging activities.
Participated in validation protocols and final report reviews.
Provided training to new staff on SOPs and GMP requirements.
Training the operators for complains of GMP, CGMP of Revised Schedule-M.
Maintained and managed records of production, raw materials, equipment calibrations and process changes, preparing monthly production plan.
Making the investigation reports regarding happened incidents.
Experience in validation coordinating with QA, QC, departments in process validation, cleaning validation and equipment validation system.
Preparing costing sheet.
Preparation of BMR, BPR and Master formulation record.
Investigation of market complaint, preparing the response for the complainant and closure of the Market complaint through proper documentation.
As a management representative & Production Executive, lead the team to obtain WHO GMP & certificate.
I have experience using seven kinds of QA tools so far. I use the check sheet to collect data, keep track of defects and record the relative frequency of defects. In standard operating procedures (SOPs) I use flow charts. I use fishbone diagrams to understand and solve problems as part of a deviation investigation.