Senior Officer – Documentation

Designation : Senior Officer

Function : Production

Functional Area : GMP Documentation

Job Role 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 Profile :

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

Job Requirements :

• Minimum 1 year of experience in GMP regulated pharmaceutical industry.
• Adequate knowledge in handling QMS Trackwise tool, Content server tool.
• Understanding of cGMP requirements

Work / Job Experience : 1 Years

Type of Experience : Pharma QA, Production documentation experience

Academic Qualifications :

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

Job Post Link : https://tinyurl.com/3jt2jsdv