Job Description

Job Description

Purpose -To support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms

Position / Job Title -Senior Executive

Department -Quality Assurance – Analytical Lab Quality Assurance

Reporting To -Manager.

Location -Ambernath

Years of Experience8-10 Years

Dosage Form-Solid Oral / Liquid experience is must, Nasal & Injectables are preferred.

Job Responsibilities / Deliverables

Rubicon Research is a specialty pharmaceutical company focused on developing high quality products using creative technologies for the global market.

Our Quality Systems, made up of policies, guidelines to ensure consistent product quality worldwide

At Rubicon, teamwork, engagement, ownership, and support by everyone are vital for achieving our quality objectives.

Requirements For The JOB
Well versed in the analytical review of documents, which includes of those from GLP section,
OOS, OOT, Events, Change control, CAPA related QMS handling
Column management, Standard handling, glassware management, chemical management




Retention samples management and review of stability sample and study management.To review of stability protocol/summary sheet.
Computer system validation, calibration & qualification of instruments. Review of audit trail from the computerized systems.
Ensure QC laboratory compliance at all times, participate in Lab check rounds.
Preparation & review of OOS/OOT/Events trending.
Review of analytical documents, chromatograms related to AMT/AMV protocols and reports.
Preparation of SOPs.
To review the Analytical reports in support of Batch release activities.
To review and approve the batches with generation of Certificate of Analysis for Finished Product.
Review Analyst qualification data.

Qualifications & Pre-requisites
Should be Graduate/Postgraduate in Science or Pharmacy
Must have knowledge on handling HPLC, GC, KF, Dissolution. FTIR, FTNIR is preferable.
Must have the exposure to LIMS

📌 Executive Ulhasnagar
🏢 Rubicon Research
📍 Ulhasnagar