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 licencesÂ
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
