Executive, R&D Development QA (DQA) / Documentation

Amneal Pharmaceuticals

2 - 6 years

4 - 8 Lacs

Ahmedabad

Posted:1 week ago| Platform:

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Skills Required

Training Equipment qualification Management systems Analytical Stability studies Internal quality auditor R&D Executive Packaging Document control Quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description

:

Review of R&D developmental data of ARD and PD like Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, Study Reports, for accuracy, data integrity and compliance to systems, procedures and regulatory requirements.
Review of Technology Transfer documents like Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications and MOAs.
Conducting routine laboratory rounds for ensuring compliance to Good Laboratory Practices.
Handling of Change Controls, Deviations, Incidents and Laboratory Assessment Reports.
Preparation, review of SOPs and conducting the SOP Training.
Conducting training of R&D personnel on Good Laboratory Practices.
Management of development stability samples i.e. protocol review, sample charging, stability calendar updation and sample withdrawal.
Receipt, issuance and management of RLDs and Exhibit batch samples.
Issuance of R&D documents like LNBs, Forms, Logbooks for routine use.
Maintaining Document Archival room of R&D. Issuance of archived documents against request.Receipt of document for archival through document inward register.
Receiving, storage, issuance and management of Working Standards, Reference Standards, Impurity standards and Chromatographic columns.
Review and approval of Instrument/Equipment Qualification and calibration records.

Skills Required:

Quality Management systems | Expert
Good Laboratory Practices | Advanced
Analytical Method Development & Validation review | Advanced
Product Development Report Review | Intermediate
Internal Quality Audits | Intermediate
Documentation Control | Expert
Review of Specification and MoAs | Expert
Stability Studies | Expert
Change Control, Deviation, Incident and Laboratory Assessment Reports | Expert
Training | Beginner
USFDA, ICH, EMA Guidelines, USP General Chapters | Advanced

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