Senior Manager Validation

Company: Sun Pharmaceutical Industries Ltd
Experience: 15+ years
Qualification: B Pharma / M.Pharma
Location: Halol (Baroda)
Responsibilities:Responsible for management of all aspects of quality engineering/validation at site for sterile formulations.Define Quality Engineering/validation goals and strategy in line with Sun Pharma compliance.Responsible for defining strategy and road map for Quality Engineering/validation activities.Effectively manage the site Quality Engineering/Validation activities.Ensure that qualification challenges are managed in a consistent and timely manner.Responsible for executing quality management review at site, monitor individual performance and set improvement plan.Accountable for designing/implementing departmental SOPs and qualification protocols.Responsible for fulfilling all training requirements of Quality Engineering/Validation team and self.Responsible for scheduling, monitoring and compliance of calibration/qualification/requalification program.Implementation of global quality standards.Review and approval of qualification/validation protocols/reports.Planning and arranging for internal and external departmental support for quality engineering activities as directed in approved protocols, quality systems or procedures.Escalation of compliance concerns.Responsible for all departmental QMS activities as well as review and approval of all assigned QMS tasks for the site.To follow cGMP for every aspect.To review documents like SVMP, EQMP, SOP, deviation, and Query Response etc.To carry out any other activities/tasks allotted by Plant Head.
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