Associate manager - Quality Assurance

Job Description:

Responsibilities

• Overall responsibilities for quality assurance compliance at the Zydus Hospira Oncology Private Limited (ZHOPL) site and Pfizer Quality & ensure sustainable GMP compliance for Pfizer Products manufactured at ZHOPL site as per Quality agreement.
• Batch record review and release authorization compliance functions:
• Responsible for review and authorize the packed batch lot(s) for distribution in respective market from ZHOPL.
• To be part of SQRT as needed for any Batch related issue discussion.
• Regulatory impact assessment for all types of change related to Pfizer products
• Responsible for Review and approval of Change controls at ZHOPL as per the Pfizer requirements.
• Responsible for performing the SCNM (Site Compliance Network Member) activities at ZHOPL and create the PAC and PCF in the PDM systems.
• Responsible for the review and approval of submission package as per procedure REG-459.
• Review BoH Queries & response and compendial/scientific data changes
• Responsible for review and approval for NPL assessment and dossier handover to ZHOPL

Qualification & Experience

• B. Pharm/ M. Pharm / M.Sc. with minimum 6+ years of experience
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, batch documents , customer complaints, investigations, Training management, change controls, document Management.
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections