Hetero Recruiting For IPQA

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs.

Role & responsibilities

Experience 3-7 Years,

Job Location:

M/s HETERO PLASMA SCIENCES PRIVATE LIMITED,

Sy.No.288, 290, 330, 330AA, 334, 335

P enjerla Village, Kothur Mandal, Rangareddy Dist., Telangana 509228.

Preferable Plasma/Biologics / Injectable only

Key Skill:

Drug substance Mandatory

Performed Activities in In Process Quality Assurance (IPQA).
To perform ipqa activities on the shop floor and responsible for giving the line clearance in each stage ofdispensing of approved raw materials, Manufacturing (compounding activity) and Filtration, Filling, Stoppering and Sealing activity.
And giving line clearance for Autoclave sterilization loads, CIP, SIP activities and vial washing activities.
I have involved and had knowledge on various types of sterile injectable presentations like vials, Cartridges, Prefilled syringes and Ampoules.
I had involved and worked with verification and monitoring of raw material Dispensing, Compounding and
filtration, filling, stoppering and sealing activities at each and every stage.
Responsible for cleaness of change rooms and respective areas, equipments, vessels.And review of Autoclave
charge reports, CIP and SIP reports, NVPC data, Tunnel and washing printout reports etc.
Responsible for Sampling and to send water for injection collection samples, bulk solution(Inprocess) samples
and bioburden samples, Nitrogen gas sampling, Finished product sampling for quality control and microbial
tests. And review that WFI, Bulk and Bacterial endotoxins test (BET) reports.
Review of Batch production and control records (BPCR).
Responsible for verification of equipment log books and area log books for accurate and completeness.
And to follow Good documentation practices (GDP) and current Good manufacturing practices (CGMP) requirements.
Responsible to follow, monitor and execution of special precautions, critical parameters and storage conditions.
To monitor and ensure environmental conditions like temperature, relative humidity, differential pressures, EMS reports during activity in Dispensing booths, Batch preparation Areas, Vial and cartridges washing areas and
Filling areas.
And responsible for giving line clearance and monitoring of visual Inspection activities.
And to perform Acceptable Quality Limits (AQL) checks and to verify the Batch Reconciliation.
Responsible for execution and to involve in Process validation Batches, Aseptic Media simulation (Media fill)
Batches, Cleaning validation batches, Stability and Hold time Studies batches. And execution and monitoring of Interventions.
Interested candidates are requested to send your updated resume praveen.ko@hetero.com/9100883352 whatsapp