Manager Compliance

Job Description:

Responsibilities

• Overall responsibilities for quality assurance compliance at the Zydus Hospira Oncology Private Limited (ZHOPL) site and Pfizer Quality at & 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
• Complaint Management for Pfizer Product
• To coordinate and ensure that ZHOPL comply with the requirements for managing complaint.
• To review and approve the ZHOPL complaint investigation reports and upload investigation reports in the Pfizer electronic complaint database.
• Support for activities including co-ordination committee meeting and share the applicable information/ distribution details to site & & Pfizer market action leader function during market action and mock recall activity.
• Quality Management System (QMS) compliance functions: Responsible for Review and approval of Investigations (QARs) initiated at ZHOPL. To be part of SQRT and involve in the Investigations. Provide support for Supplier management. To provide Quality support for review of documents for new product launches and Tech transfers as needed Responsible for reviewing and approval of Process validation related performed at ZHOPL.
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• Other: To support any additional and urgent activity in absence of primary responsible person as assigned by the Manager. Responsible to support with the AQRT /ESQRT process as and when required. To provide Quality support for new product launches and Tech transfer as and when needed
• Pfizer Revolution Global SOPs management activities: Responsible for role of LPO for processes for Pfizer, Accountable for local process performance. Several LPOs could be assign to each L2 process, depending on local process requirements.
• Any other responsibilities assigned by the Manager.

Qualification & Experience

• B. Pharm/ M. Pharm / M.Sc.
• 10+ years of pharmaceutical industrial experience.
• Exceptional organizational and project management skills
• Demonstrated strength in analytical skills and meticulous attention to detail
• A solid understanding of the regulatory and audit frameworks pertinent to biopharmaceutical operations
• Proficiency in taking decisive action based on quality and compliance metrics and trends
• Capable of managing multiple complex projects with a strong sense of business acumen
• Excellent interpersonal effectiveness, coupled with superior written and verbal communication skills