Senior Executive-Quality Assurance

To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form.
To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc.. and responsible for assigning the QRM no. To review all labelling related artwork components for products. To prepare artwork information details for new / revised labelling components and submit to QA doc cell for issuance of artwork as per procedure. To review and verify the destruction of old printed packaging materials (vendor and Amneal site) in case of revision of artworks of labelling components. Tracking the actions, review of extensions, verification of documents and closure of actions. Responsible for document handling, issuance, distribution, and retrieval of document. Scanning of documents for regulatory submission To maintain master documents like Site Master File, Validation Master Plan, Quality Manual, SOPs, protocols, reports, Batch Records, specification, method of analysis, drawings, artworks, planners, etc.. Responsible for issuance, archival and retrieval of documents like SOPs, Validation / qualification protocols / reports, Batch records, Specifications, Drawings, Artworks, planners, etc.. To provide BMR/BPR numbering to exhibit, intended and media fill BMR. To provide Batch number to exhibit, commercial, feasibility and medial fill batches. To receive and distribute the product development documents like Master Formula Records, Master Packaging records, protocols (sampling, study, and stability protocols). Issuance of uncontrolled copy / reference copies of master document to user as and when requested by user. To provide requested documents to regulatory affairs department for regulatory submissions (AR or other submissions), whenever required.

Artwork management that includes effective the Artwork information details, distribution, retrieval and archival of artwork and all labelling components.
To retire the documents as per change control assessment / proposal. Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HODs instruction and guidance.

Skills:

Monitors production processes in real-time to ensure compliance with specifications and GMP, Batch record review, process monitoring, sampling, quality checks, real-time deviation management.

M.Sc. / B. Pharm / M. Pharm