Executive - Documentation - Production Operations Support

Job Summary

• A role-holder Initiation & review of batch documents for new launch, site transfer commercial documents and batch documents for trials. Assist in process of QMS activities timely closure in compliance with regulatory standards and procedures.

Job Responsibilities

• To be self-disciplined & maintain the same discipline in the production department.
• To maintain the safety and housekeeping practices at work place.
• To ensure training of our self on current version of procedure prior to perform activity.
• To perform the activities assigned to him by the concerned section seniors or by his superiors in area.
• To showcase the value of collobaration with own/other departments to complete the work assigned.
• To escalate immediately to concerned superior / manager for any deviation / non-compliance /abnormal observation.
• Shall always be ready to accept new challenges & multifunctional activities.
• Shall always stick to the time line provided or assignment given by superiors, to avoid any delays and any non-compliance.
• Works as a member of a team to achieve all outcomes.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• To plan the production activities as per the weekly plan on daily basis
• To coordinate for timely completion of Change Control Packages (SAP Master Data, Master Documents for intended documents ) in QMS Track Wise for New Launch/Site Transfer/Submission batch documents.
• Ensure support for timely completion of Investigations for document related deviations.
• Ensure timely completion of document revision (if any) in response to CAPA.
• Initiation and approval for Batch documents, SOPs and Formats in Content server.
• Sort out trouble shooting in SAP related to ZDOC Print (Meta data entry, Resource etc)
• Update and maintain SAP master data related to product.
• Ensure all changes are aligned with cGMP regulations and corporate SODs.
• Develop and maintain effective working relationships with internal and external customers.
• 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.

Job Requirements

• Education
  • GBDM
  • DCTTC
• Knowledge, Skills and Abilities
  • Adequate knowledge in handling QMS Trackwise tool
  • People management skillset
  • Adherence to cGMP
  • Exhibit Perseverance in all the tasks performed 
• Experience
  • 0-5 yrs