Title:  Senior Manager Validation

Role : Senior Manager (Validation)

Experience : 15+ years 

Qualification - B Pharma /M.Pharma 

Location : Halol (Baroda)

• Responsible for management of all aspect of quality engineering / validation at site for sterile formulations.
• Define Quality Engineering/va1idation 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 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 requirement of Quality Engineering/Validation team and self.
• Responsible for scheduling, monitoring and compliance of calibration /qualification

/requa1ification program.

• Implementation of global quality standard.
• 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 carryout any other activities / tasks allotted by Plant Head.