A core quality professional equipped with over 32 years of experience in Pharmaceutical Manufacturing Organizations, with wide experience in handling various disciplines: :Quality Assurance ,Quality Control, Microbiology, Training and Development, Audits and Vendor Qualification.

Worked in API -Sterile and Non-Sterile/Medical Devices/Sterile Finished formulations -Dry Powder Injections/Ophthalmic/Oral Solid Dosages manufacturing facilities.

Extensive experience in the Establishment, Continuous improvement and Sustenance of quality systems through procedures, guidelines etc., Customizing Trainings to employees on Data Integrity,  Reduction of QMS elements related to Human Errors, Quality Culture and various regulations. Understanding and interpretation of regulatory and GMP GLP/GDP/compliance rules, regulations and guidelines for cost effective implementation of Quality System within the organization. Ms Balwinder is involved in conducting the gap assessment of the facilities (core area Quality Control, Microbiology, Clean Room Areas) through audits and mitigating the risk.

Expertise:

• Expertise in conducting audits and gap assessment of Quality Control, Microbiology, Quality System.
• Verification of CAPA’s efficiency .
• Training on Data Integrity, GMP/GDP/GLP/Computer System Validations ,Quality Risk Management, Good Microbiological Practices
• Remediation and Regulatory compliance.
• Assessment of Data Integrity related issues in Laboratory System.
• Technology Transfer and Analytical Method Validations
• Involved in conducting Risk Assessment for Products, Processes and Environment Monitoring Program.
• Audits -Vendor Qualification Program, Third Party and Due diligence Audits.
• Computer System Validations of QC and Micro System.
• Reviewing of Investigations related to OOS, Deviations, Incidents, Microbial Data Deviations ,OOC, OOT.
• Improving the productivity of QC labs by streamlining processes through end to end mapping,
• Qualifications ,Validations, Method Development
• Change Management System