CIPLA HIRING JUNIOR QA MEMBER
2 Years
Salary :
Rs. 22000 – Rs. 70000
Rangpo, Sikkim
Review The Compliance Level Of The Site For Deficiency Response, Prepare Master Validation Protocol And Report As Per Company Quality Policy And Applicable Regulatory Guidelines.
Position:
Junior Team Member – QA
Department:
Quality Assurance
Education:
B. Pharma/ M.Sc
Job Location :
Rangpo, Sikkim
Job Description
I. Collate, Review, And Provide Required Work Plans On Received Deficiencies To HO To Respond To Regulatory Authorities Promptly.
II. Review Master Validation Protocol And Report For Timely Execution Of Validation Batches And Submission Of Documents For Deficiency Response.
III. Review Annual Product Quality Review Report At Units For Completeness And Data Correctness To Ensure Compliance With CGMP Requirements And Audit Readiness.
IV. Review, Upkeep, And Issue Regulated Market Technical Agreements At The Site For Batch Execution As Per Customer Requirements.
V. Receive And Distribute Approval Certificates, Dossiers (TDP & RAP), And Development Reports At The Unit For Smooth Execution Of New Products.
VI. Coordinate With Auditors And Site Teams For Regulatory And Customer Inspection/Audit To Meet Regulatory Expectations And Acquire GMP Approvals.
VII. Prepare The Final Draft Of Compliance To Audit Observations And Ensure Alignment With CGMP Requirements To Avoid Regulatory Action.
VIII. Collect, Compile, And Review Raw Data And Finalize For Timely Submission Of MHRA, UK Interim Update Documents To Corporate As Per Agency Requirements.
IX. Drive Continuous Improvement Initiatives In CQA To Facilitate Adherence To CGMP.
X. Execute On-Time And Errorless Submissions By Reviewing Product Licenses, Certificates, Staff Approvals, And Other Applications To Adhere To Legal Requirements.
XI. Support In CDSCO And State FDA Inspections To Ensure GMP Compliance And Obtain Product Licenses, FDA Stall Approvals Through Cross-Functional Interaction.
Education Qualification:
B. Pharma/ M.Sc
Relevant Work Experience:
2 Years Of Experience In The Quality Assurance Department.
Competencies/Skills:
Collaborate To Succeed
Innovate To Excel
Perform With Accountability
Lead With Empathy
Act With Agility
Strong Domain Knowledge
People Management
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