Assistant Manager-APIPL-PSV AP

Coordinate with concerned department for monitoring /tracking of change control for its effective implementation and clouser of Change controlin an timely manner.

• Review of the MBPCRs and MGCRsfollowed by change control impact assessment pror to approval.


• Review of the excuted BPCRs /GCRs and Manufactiring related documentation support.


• To insure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.


• To monitor and ensure the Dispatch activities initiated after the Quality release.


• To coordinate with the manufacturing team to address any Quality issues arises during manufacturing.


• To support for addressing Deviation,lnvestigation and Change control change control activity.


• Equipment and area clearance certification for product changeover.


• To perform the SAP related activities.


• Handling of Deviation /CAPA related to manufacturing.


• Preparation and review of the Protocol and report, monitoring of the Process and cleaning validation activities.


• Preparation and review of cleaning evaluation report.


• Preparation and review of annual Product Quality Review(APQR).


• Preparation and revision of the Departmental SOP ,Form and Annexures.


• Monitoring of the cGMP compliance through Plant rounds


• To adhere the EHS policy & procedure in routine activities.


• To involve in EHS related activities on need basis.


• Works in a safe manner collaborating as a team member to achieve all outcomes.


• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.


• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.


• All other relevant duties as assigned.

• Education

  
  
  • M.Sc./ M. Pharma
  
  
  
  

• Experience

  
  
  • 6-10 year experience, with demonstrated skill in preparation of protocol and reports, monitoring of process validation, etc.