Posted:-1 days ago|
Platform:
Work from Office
Full Time
To design, establish and maintain appropriate Quality Management Systems to meet the dynamic regulatory demands, customer specific requirements, and local statutory requirements and ensure continued compliance to the same.
Direct responsibilities include but not limited to the following:
Overall compliance status of the Plant across all functions.
Implementation of Quality Management System.
Overall qualifications (facility, equipment etc).
Overall validations at Plant (process, cleaning, etc)
Overall audits at Plant (regulatory and customer).
Development of quality systems and training of people.
Creation and execution of SOPs across all functions in conjunction with department Head’s.
Manpower, revenue and capital budgeting of QA function.
Indirect responsibilities include but not limited to the following:
Release and dispatch of goods.
Review of associated documentation and final approval related to the above.
Approving or rejecting incoming materials.
Work closely with DQA, particularly for Vendor Qualification.
Work closely with Regulatory department for regulatory matters which need quality input.
Work closely with Manufacturing, PPIC and QC to ensure smooth Plant operations leading to timely dispatch of goods as per GLP and GMP.
Delegation of authority: In absence of Head QA , Senior Manager and above can sign any GMP document as designee for Head QA.
Must have experience in Parenteral, Liquid, Nasal, Sterile dosage forms. & should have worked in USFDA setup
Rubicon Research
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