Team Member QA

3 days ago

Indore, Madhya Pradesh, India Hector And Streak Consulting Full time ₹ 95,00,000 - ₹ 1,00,00,000 per year

Team Member QA

Job Locations: Indore

Required Experience: 5 - 8 Years

CTC : 9.50LPA

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.

Relevant Work Experience

Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Education Qualification

B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department

Licensing and registration (0-2 years).

Job Responsibilities:

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

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

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

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

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

  6. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals

  7. 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

  8. 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.

  9. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP

  10. 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.

  11. Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval

  12. Communicate with FDA to resolve queries and follow ups to monitor status of application
  13. Review, maintain and distribute approved certificates to concerned stakeholders at site
  14. Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site
  15. Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act

  16. Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition

  17. Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction

  18. FDA for processing and approval of application (need basis)

  19. Process of identifying root cause for the observation in various inspection and audit (to CFT)

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