Roles and Responsibilities
Experience in Managing a QA team on day-to-day basis.
Analysis in a supervisory role, with strong knowledge of Drug & Pharma Audits as per cGMP & GLP, USFDA,WHO requirements
Plan and conduct internal audits, study audits and routine process audits for as per cGMP, GLP requirements
Ensure timely and effective CAPAs (Corrective Actions & Preventive Actions)
Ensure compliance to cGMP, GLPs and Company’s quality system requirement
Sound knowledge of GDP & internal Audit Requirements
Train the team members on cGMP requirements, pharmacopoeia updates & Regulatory requirements
Ability to monitor laboratory operations systems, develop new capabilities and act on improvements with key performance indicators
Write & review SOP's with focus on quality system improvements
Experience & knowledge in Laboratory Information managements software (LIMS)
Ability to effectively organize routine and complex work
Ability to negotiate effectively with other departments and functions to improve processes.
PG:M.Pharma in Any Specialization,MS/M.Sc(Science) in Organic Chemistry
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