Executive/ Sr. Executive- Qa(qms) Job in Leben Life Sciences

Executive/ Sr. Executive- Qa(qms)

Leben Life Sciences 4+ weeks ago

Akola, Maharashtra
Not Disclosed
Full-time
Permanent

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Job Summary

Minimum experience required in this position:

5+ years

Description:

Roles & Responsibilities :-

Preparing and reviewing Site Master File, Validation Master Plan, Master Batch Records, Departmental Manual, and data integrity policy.

Executing and compiling equipment qualification, HVAC qualification, facility qualification, temperature mapping of areas.

Performing cleaning validation, process validation, and hold time study of drug products.

Preparing, Reviewing & Executing Water System and Compressed air Protocol.

Ensuring adherence to quality standards & maintaining all the related documents conducting inspections at various stages to ensure safety & quality specifications are met without any slippages.

Steering the implementation of cGMP for all operational activities.

Conducting Audits and ensuring compliance and audit readiness reviewing analytical report.

Imparting Training, conducting online on job as well as classroom training for cGMP, cGDP to support subordinates.

Participating in Internal Audits to ensure quality in other departments like Production, Warehouse, Engineering & QC and so on.

Addressing market compliances, deviation, CAPA, and change Finalizing Artwork and Specification for Printed Packaging Materials.

Checking and preparing all the dimensions of art work specification for Printed Packaging Material

Checking and preparing all the dimensions of art work and send it to pack pilot for approval

Participating on PLC/CSV validation activities

Reviewing of Batch Manufacturing Records and bill of material

Preparing and reviewing of Annual Product Quality Review.

Reviewing Instructions, Packaging configurations Artwork, Shade cards, Specimen printed packing material Specifications, Standard Test Procedures, Record of Analysis Report, General Analytical Method and Stability Protocol

Following instructions given by HOD.

Highest Qualification :-

B.Pharm / M.Pharm / B.Sc / M.Sc

Location :-

Akola

Experience Required :

Minimum 5 Years

Vacancy :

2 - 4 Hires