Website:
umendrals.com
Job details:
About us
Umendra Life Sciences manufactures OTC topical formulations — creams, gels, ointments, lotions — at our plant near Bavla, Greater Ahmedabad. Most of our output goes to the US and other regulated export markets, which means our customers audit us directly and our documentation gets read by people who are looking for problems.
The roles
We're hiring QA personnel across seniorities - Executives, Senior Executives and Officers - and across four areas, reporting into the Assistant Manager and DGM Quality Assurance.
In-Process Quality Assurance (IPQA)
- Own line clearance and in-process checks for your assigned lines — you sign it, you stand behind it
- Verify batch execution against the BMR in real time, on the floor, not reconstructed afterwards
- Raise and document deviations as they happen and drive them to the right owner
- Hold the line on in-process parameters when the schedule is under pressure
Qualification & Validation
- Own equipment qualification end-to-end — protocol drafting, execution, deviations, report closure
- Drive cleaning validation for semi-solid lines, including worst-case product selection, swab locations and recovery studies
- Own the calibration schedule across the plant and keep it current
- Run the stability programme and control sample management to protocol
Batch Records & Documentation
- Own BMR/BPR review end-to-end, from issuance through in-line verification to closure
- Control document issuance, retrieval and revision so the master list is accurate at any given hour
- Ensure batch documentation is audit-ready before it's filed, not after a request comes in
Quality Systems
- Own change controls and deviations from initiation to closure — including chasing other departments for their part of it
- Investigate market complaints and drive CAPA through to effectiveness checks, not just closure dates
- Compile APQRs and own process validation, self-inspection, SOP preparation, vendor qualification and training records
- Prepare for and face customer and regulatory audits, and close out observations
Who we're looking for
Your QA experience needs to be plant-side, in pharma or personal care manufacturing. Corporate quality, trading and distribution backgrounds don't transfer to this.
Beyond that:
- 2–10 years, depending on the level you're coming in at
- Experience at a USFDA or WHO-GMP audited site is a strong plus
- Topicals or semi-solids exposure is valued; if you've only worked solid orals, expect cleaning validation, homogeneity and fill-weight to be harder here than you're used to
- B.Pharm, M.Pharm or M.Sc
- Working knowledge of GMP, SOP systems, batch record review, CAPA and vendor qualification
What we actually screen for is narrower than the qualifications: whether you hold your position when production is behind schedule and wants the batch released. Most of the rest is teachable.
What this role is not
- Not a head-office or corporate quality role
- Not remote or hybrid
- Not a documentation-desk position insulated from the shop floor — you'll be on the floor
- Not a role where you inherit a finished system and run it. If you'd rather maintain something that already works than build it, this will frustrate you
- Several IPQA positions are night shift. We'd rather say that now than at offer stage
Click on Apply to know more.
