Senior Officer - Documentation

Job Summary

A role holder to Prepare batch documents (MMaRs and MPaRs) for new launch, site transfer, Commercial batch documents and batch records for trials. Initiation of QMS activities and timely closure in compliance with regulatory standards and procedures.

Job Responsibilities

• Initiate Master Manufacturing Records (MMaRs) & Master Packaging Record (MPaRs)


• Initiate Placebo and Optimization batch record for trails.


• Initiate Change Controls in QMS Track Wise for New Launch / Site Transfer / Submission batch / SOPs / Formats and commercial batch documents.


• Ensure QMS Change control closure within the stipulated timeline.


• Ensure support for timely completion of Investigations for document related deviations and document revision based on CAPA.


• Initiation of batch documents , SOPs and Formats in Content server.


• Check Monthly Schedule to ensure document readiness.


• Ensure all changes are aligned with cGMP regulations and corporate SODs.


• Perform all work in accordance with established regulatory, compliance and safety requirements.


• Coordinate with NPL and RA regarding Deficencies from Regulatory Agencies and Clarifix.


• 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.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  
  
  
  • Minimum Bachelor of Pharmacy / Science or any equivalent degree.
  
  
  
  


• Experience
  
  
  
  • Minimum 1 year of experience in GMP regulated pharmaceutical industry.
  
  
  
  


•  Knowledge, Skills and Abilities
  
  
  
  • Adequate knowledge in handling QMS Trackwise tool, Content server tool.
  
  
  • People management skillset
  
  
  • Adherence to cGMP
  
  
  • Exhibit Perseverance in all the tasks performed
  
  
  • Problem solving skills
  
  
  
  

Exigences liées au poste