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Encube Ethicals Recruiting For Sr. Executive / Executive – CSV (IT – QA)

Encube Ethicals Recruiting For Quality Assurance/Quality Control Executive .Encube Ethicals is an integrated pharmaceutical topical organization dedicated to only semisolid formulations since 19+ years..Our focus is to consistently excel in manufacturing and development of topical formulations which touches millions of patients globally. For everything that Encube does, we intend to delight Encubians, business partners and end consumers by going beyond their expectations every time.

Eligibility  and other details :  

  • Post Name: Quality Assurance/Quality Control Executive
  • Qualification: B.Pharma with 05-09 Years of Experience
  • Location: Mumbai
  • Salary: Not Disclosed
  • No Vacancies: 01
  • Selection Process : Based on Resume Received,will shortlist.
Job description:

§ Performing the computer system validation as per 21 CFR part 11, GAMP5 and Annex 11.

§ Preparation of various documents related to the Qualifications of software and instruments/ equipment.

§ Perform GxP assessment and System Classification, 21 CFR assessment of analytical software.

§ Preparation of URS, Validation plan, Functional specification, Installation Qualification, Operation Qualification, Performance Qualification, Risk Assessment, traceability matrix and validation summary report for software.

§ Execution of Installation Qualification, Operation Qualification and Performance Qualification for various instrument systems, PC interface, SCADA software.

§ Monitoring user Management, Backup and restoration activities. And Help in Execution of operational part of software.

§ Review of Qualification documents such as, VPP, CS, IQ, and OQ, PQ.

§ Raising Discrepancies observed during qualification, evaluate the discrepancies and proposed the CAPA actions.

§ Handling of change control related to CSV, documents, infrastructure, SOP.

§ Work as administrator for Firmware based systems i.e. Balance, pH Meter etc.

§ Performing Quality risk Management at different stages of Instrument/ equipment and software system qualification.

§ Following and monitoring requirements of cGMP and data integrity

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