Analytical Lab Quality Assurance- Executive/Sr. Executive/ AM

Rubicon Research; Thane; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Rubicon Research in Ambernath, Maharashtra, seeks an Asst. Manager for the Analytical Quality Lab. You will oversee GLP reviews, stability and retention protocols, instrument validation, and QA documentation to support batch release and COA processing.

You will lead a team, coordinate with QC, Manufacturing, and Engineering, ensure time-lab compliance, and drive continuous improvements in the QA lab processes.

Qualifications

• Must have hands-on experience with HPLC, GC and KF analyses.
• Exposure to regulatory bodies like US FDA, MHRA, TGA.
• Experience with dosage forms such as OSD, Liquid Orals and Nasal formulations.
• Strong team coordination and cross-functional planning.

Responsibilities

• Well versed in analytical review including GLP and lab support systems.
• Retention sample management, stability management and review of stability protocol/summary sheet.
• Computer system validation and instrument calibration/qualification.
• Review of audit trail and ensuring compliant lab operations.
• Handle QMS records like OOS/OOT, CAPA, Change Control and Deviation.
• Prepare/review analytical documents: worksheets, chromatograms, AMT/AMV.
• Review of specifications and STP.
• Review analytical reports for batch release activities.
• Review and approve COAs from QC for finished product, raw material, packaging material.
• Review Analyst qualification data.
• Lab rounds and internal auditing checks.
• Lead the group in Manager's absence for planning and coordination.

Skills

HPLC

GC

KF

FT-NIR

LC/MS

Regulatory exposure

Dosage forms

Team coordination

Planning

Job description

Purpose

To support Lab - Analytical Quality and compliance is maintained as per the GMP norms

Position / Job Title

Asst. Manager

Department

Quality Assurance Analytical Lab Quality Assurance

Reporting To

Manager – Analytical Lab Quality Assurance

Location

Ambernath

Years of Experience

~12 Years

Dosage Form

Solid Oral / Liquid, Nasal / Injectables is preferred

Job Responsibilities / Deliverables

• 1) Well versed in the analytical review which includes review of GLP, Lab support systems like Column management, Standard handling,
• 2) Retention sample management, stability management & review of stability protocol/summary sheet
• 3) Computer system validation, glassware cleaning validation, calibration & qualification of instruments
• 4) Review of audit trail.
• 5) Ensure all time laboratory compliance.
• 6) Handling of QMS records like OOS/OOT, CAPA, Change Control, Deviation and making the trend reports.
• 7) Review of analytical documents which include worksheet, chromatograms, AMT/AMV.
• 8) Preparation, Review of specification & STP.
• 9) To review the Analytical reports in support of Batch release activities
• 10) To review and approve the Certificate of Analysis received from QC for Finished Product, Raw material, Packing material
• 11) Review Analyst qualification data
• 12) Check rounds of lab and internal auditing
• 13) Leading the group independently in the absence of Manager for planning and coordinating with the other functions (CFT)

Qualifications & Pre-Requisites

Must-Have Skills:

• Must have knowledge on handling HPLC, GC, KF. Exposure to FT-NIR, LC/MS is additional advantage
• Exposure to various regulatory bodies like US FDA, MHRA, TGA
• Exposure to specific dosage forms like OSD, Liquid Orals, Nasal formulations is must
• Team coordination and work distribution
• Planning for the team and coordination with functions like QC, Manufacturing, Engineering, Warehouse.