Manager 1

Sr. No.

Responsibilities

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To facilitate harmonize and consistent implementation of Quality System and procedures at site alignment with Corporate Quality Policies/Procedures.

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To review documents pertaining to QMS & Compliance.

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Responsible for ensuring compliance of Quality Management System.

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To attend Site Training Program as per site training program and Global Quality Standards requirements.

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Dossier documents Submission after review against request received from Corporate regulatory affairs.

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Query response for submitted dossier against request received from Corporate regulatory affairs.

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Export dispatch related query response for approved art work of printed PM, Primary-packing material, overprinting and if other requirement is there.

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Export Harmonization activity between existing and new change implement for Product.

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Review and approval of change control and deviation through QMS software and prior approval activity from Regulatory if require as an impact analysis with require detail.

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Initiation of extension and variation proposal through QMS software

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Regulatory impact handling for Pharmacopoeia change like IP,BP,USP implementation for export market products.

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Location RA - Approval to Process Validation summary. Other departmental documents where signature require as location regulatory approval like APR, etc.

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Product approval package review, approve and share approval detail to respective department.

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Any Additional activity allocated by the department head and site head.