Quality Assurance Pharmaceutical (Mumbai)

Quality Assurance Pharmaceutical (Mumbai)

05 Aug
|
Umendra Life Sciences
|
Mumbai

05 Aug

Umendra Life Sciences

Mumbai

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 itVerify batch execution against the BMR in real time, on the floor, not reconstructed afterwardsRaise and document deviations as they happen and drive them to the right ownerHold the line on in-process parameters when the schedule is under pressureQualification & Validation

Own equipment qualification end-to-end — protocol drafting, execution, deviations, report closureDrive cleaning validation for semi-solid lines, including worst-case product selection, swab locations and recovery studiesOwn the calibration schedule across the plant and keep it currentRun the stability programme and control sample management to protocolBatch Records & Documentation

Own BMR/BPR review end-to-end, from issuance through in-line verification to closureControl document issuance, retrieval and revision so the master list is accurate at any given hourEnsure batch documentation is audit-ready before it's filed, not after a request comes inQuality Systems





Own change controls and deviations from initiation to closure — including chasing other departments for their part of itInvestigate market complaints and drive CAPA through to effectiveness checks, not just closure datesCompile APQRs and own process validation, self-inspection, SOP preparation, vendor qualification and training recordsPrepare 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 atExperience at a USFDA or WHO-GMP audited site is a solid plusTopicals 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 toB.Pharm, M.Pharm or M.ScWorking knowledge of GMP, SOP systems, batch record review, CAPA and vendor qualificationWhat 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 roleNot remote or hybridNot a documentation-desk position insulated from the shop floor — you'll be on the floorNot 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 youSeveral IPQA positions are night shift. We'd rather say that now than at offer stage

📌 Quality Assurance Pharmaceutical (Mumbai)
🏢 Umendra Life Sciences
📍 Mumbai

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: quality assurance pharmaceutical (mumbai) / mumbai

Subscribe to this job alert:

Get the latest job offers by email for: quality assurance pharmaceutical (mumbai) / mumbai