Posted:2 weeks ago|
Platform:
Work from Office
Full Time
Executive for Micro R&D 1 Post based in Amritsar. The ideal candidate brings 6 - 8 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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