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Intas
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Senior Executive

Senior Executive

Intas

4 - 8 years

5 - 11 Lacs

ahmedabad

Posted:4 hours ago| Platform:

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Skills Required

qa compliance internal audit quality technical agreement revision sop external audit gmp extended capa audit observation gap assessment capa usfda sop review audit response sop preparation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Summary Job Functions:

Audit and Compliance, Quality Technical Agreement, Gap Assessment, Extended CAPA

Key Responsibilities:

- Drive the self-inspection program at Intas-Biopharma site. Ensure the self-inspection program run as per defined schedule.

- Perform risk assessment to determine the frequency of the self- inspection. Ensuring the appropriate CAPAs are identified and implemented in appropriately.

- Management of external quality audits. Responsible to facilitate for the management of backroom, coordinate the auditors request, works as scribe during audit, preparation of response etc 4. Tracking and follow up of internal and external audit CAPA.

- Verification of CAPA effectiveness of internal and external audit CAPAs.

- Provide the necessary information/support to health authority, business partner and customer as per regulations and agreement respectively.

- Preparation and review of the Quality Technical agreement with Business partner/Customer. Follow up and track the renewal of the Agreement with stakeholders.

- Gap assessment of corporate guidelines, other site audit observations, regulatory guidelines.

- Gap assessment of extended CAPA from the other site and tracking of CAPA.

Summary Job Functions:

Audit and Compliance, Quality Technical Agreement, Gap Assessment, Extended CAPA

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Intas

Pharmaceuticals

Ahmedabad

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Senior Executive