Division

Department

Sub Department 1

Job Purpose

Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines

Key Accountabilities (1/6)

Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner

• Collect data from all SPOCs with respect to received work plan for review
• Escalate any delays in receiving response from unit with respect to work plan
• Review of collected data for work plan fulfilment
• Send data to HO for compilation of deficiency response
• Take follow up with HO to receive updated dossier for product updates
  
  

Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies

• Review master validation protocol and report within timeline
• Check major observation in other units documents also for improvement of validation documents at site
• Synchronize all units Validation documents for improvement of all units
  
  

Key Accountabilities (2/6)

Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness

• Collect APQR timely with units for review
• Review data with supporting documents for data authentication
• Check major observation with other units for improvement of documents at site
  
  

Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement

• Review and compile received technical agreements for comments
• Provide guidance for execution of batches and handling events as per customer requirement
• Provide training in department to improve awareness in audit and compliance with licencing department
• Take follow up with HO for providing fresh TA and pending TAs for products
  
  

Key Accountabilities (3/6)

Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly

• Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site
• Update site on receipt of documents for handling execution of customer or market specific batches
• Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
• Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements
• Inspect audit prerequisites to support and prepare for external audits
• Coordinate with Units for preliminary draft response and prepare final draft within timeline
• Follow up for closure of compliance commitments
• Provide adequate, errorless and timely compliance to CQA
• Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review
• Prepare and submit EPA annual production application for getting the establishment registration of unit V
  
  

Key Accountabilities (4/6)

Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning

• Coordinate with units for all the raw data, its review and finalization before submission to corporate
• Prepare pre-inspection compliance report after announcement of MHRA audit
  
  

Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP