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Micro Head - R&D

Micro Head - R&D

Naukri Healthcare Jobs

10 - 15 years

|

12 - 16 Lacs

Posted:5 hours ago| Platform:

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Skills Required

cgmp data integrity gmp ich who method validation erp quality control analytical method development scale up anda microbiology hplc analytical method validation lims r qc quality assurance research and development regulatory affairs coaching doe

Work Mode

Work from Office

Job Type

Full Time

Job Description

The ideal candidate brings 10- 15 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments
Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety
The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen)
Lead microbiology practices including EM, MLT, sterility assurance, water/air monitoring, microbial ID/trending, and method validation; establish contamination control strategy and support media fills and aseptic behaviors
Support R&D/formulations: experiment planning, DoE, scale-up/tech transfer, method/cleaning validation, and dossier documentation aligned to global registration needs
Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment
Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus

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