Deputy General Manager, QA Validation

Essential Functions :

• To ensure that validation system remain updated as per regulatory requirements and industry standards.
• Responsible for execution and review of Qualification / Re-Qualification and Validation activity ofEquipment / System / Facility and Plant utilities.
• Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respectiveQualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
• Responsible to conduct sampling activity as per the protocols (Process Validation, Cleaning Validationetc..).
• Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.
• Responsible for preparation and follow up for collection of data related to Annual validation planner.
• Responsible for submission of qualification documents to RA as per requirement.
• Responsible for review of media fill BMR.
• Responsible for IPQA activities as per requirements.
• Responsible for review and approval of documents like Validation protocols, reports, QRM, SOPs etc..
• Responsible for the assessment & review of Change Control, Deviation, CAPA, Investigation etc..
• Responsible for approval of URS, DQ and vendor / suppliers documents related to qualification.

Additional Responsibilities :

Education :

Experience :

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Specialized Knowledge : Licenses :

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.