Twenty years inside the plant, not outside it

Background

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Why the progression matters to the work

Selvinium Solutions is led by Himansu Khandhedia, M.Sc. (Chemistry), whose twenty years in the pharmaceutical industry span quality assurance and quality control, production and projects, and distribution and operations — rising from QA Officer to Site Head – Quality Assurance, Deputy and Assistant General Manager – Quality Assurance, and operational leadership at Chief Operating Officer level.

That progression matters to the work. A consultant who has only audited will write a report. A consultant who has held the licence, signed the release, and defended the decision to an inspector writes something a site can act on — because he has had to act on it himself, with the same production pressure and the same budget.

Compliance that was built five years ago does not automatically meet the standard being applied today — and the gap is usually found in the layout, the qualification file and the data, not in intent.

What clients come with

Typically one of four situations: an inspection is scheduled, an observation has landed, a new line or block is being built, or a regulatory change such as the Revised Schedule M has made the current system insufficient. In each case the need is the same — an accurate read on the gap, and a plan that can be executed with the people and the budget actually available.

How the practice is set up

The person who scopes the assignment is the person who does the work. Support is delivered at the plant, off site, or as a continuing arrangement of periodic visits with remote review between them — and wherever possible the site's own team carries out the work under guidance, so that competence stays in the building after the assignment closes.