Executive - Quality Assurance

sun pharma industries

5 - 12 years

7 - 14 Lacs

dahej

Posted:1 week ago| Platform:

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Skills Required

manager internal audit lms ipqa edms pharma analytical shop floor manager quality control gmp auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review of Audit Trail for Chromatographic & Non-Chromatographic Systems.
Ensure implementation of relevant quality policies, standards and procedures for computerized systems.
To review and identify gaps of Global Quality Standards/Global Standard Operating Procedure with Site SOPs. To implement the Global Quality Standards/Global SOPs at site.
To prepare the Departmental Annual Training Planner and tracking for the same.
To work as Departmental Training Co-ordinator for Learning Management System.
Overall responsible for training activities for QA Department.
To review the SOPs of all departments before approval.
Update data in master drive.
System GAP assessment/GMP Trending/escalation/shop floor round.
To review QMS (Deviation, Change Control, CAPA, etc.) related to Quality Control/Micro and QA-IT.
Review and Approve validation deliverables and lifecycle documentation for computerized systems.
Review and release of analytical documents in LIMS.
Participation in handling OOS, OOT and Lab event investigation.
Ensure resolution of identified risks/gaps related to computerized systems in a timely manner.
Handling of EDMS activity.
External audit/Internal audit/Regulatory Audit Management.
Compliance/Response to audit and inspection.
Regulatory compliances over view.
Readiness/Preparation of audits.
Preparation and Review of Site Quality Monthly Report.
Preparation of Site Master File & Quality Manual.
Other activities instructed from time to time.

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