Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Cipla
Designation : Junior Team Member
Function : Quality Assurance
Functional Area : Site QA, License & Registration
Job Role Summary : Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines, Documentation for state licences 
Job Profile :
  • Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
  • Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies
  • Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
  • Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
  • Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
  • 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
  • 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
  • Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
  • Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site
  • Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site
  • Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements
Job Requirements :
  • Three/ four year of experience in quality assurance department
  • Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system
  • Experience in Licensing and registration (0-2 years) with state drug licensing authorities
Work / Job Experience : 2 Years
Academic Qualifications :

B. Pharma/ M.Sc

To apply for this job please visit careers.cipla.com.