Senior Executive

Rubicon Research Limited; Indore; On-site; INR 500,000 - 800,000; Full time

Job summary

Rubicon Research Limited in Indore is seeking an Executive/Sr. Executive (Reviewer) for their Analytical Method Validation department. The role involves planning and allocation of analytical work for method validation and verification. Candidates should have a Bachelor or Master Degree in Science or Pharmacy, with 6 to 10 years of relevant experience, and knowledge of chemical analyses and instrumentation. Preferred experience includes working in US-FDA/MHRA approved companies. The position requires good communication skills and the ability to work in shifts.

Qualifications

• 6 to 10 years of experience in analytical data review and knowledge of chemical analysis.
• Experience in handling, initiating, executing, and approving incidents and investigations.
• Experience in US-FDA/MHRA approved companies preferred.

Responsibilities

• Plan and allocate analytical work for method validation and verification.
• Prepare and review SOPs, protocols, and reports.
• Coordinate with Analytical Development for timely prerequisites.

Skills

Analytical data review

Knowledge of chemical analysis

Knowledge of instrumental analysis (HPLC/GC/UV/IC/IR/KF/Dissolution)

Good written and communication skills

Ability to achieve deliverables with minimal supervision

Education

Bachelor or Master Degree in Science or Pharmacy

Tools

Empower software (Waters HPLC)

Job description

Job Details

• Job Title: Executive / Sr. Executive (Reviewer)
• Department: Analytical Method Validation
• Location: Indore
• Reporting To: Assistant Manager / Manager
• Years Of Experience: 6 to 10 years
• Dosage Form: Solid Oral / Nasal / Liquid

Overview

The role involves daily work planning and allocation of analytical work for method validation, method verification, and method transfer for API and finished products.

Responsibilities and Deliverables

• Plan and allocate analytical work for method validation, method verification, and method transfer for API and finished products.
• Prepare and review SOPs, Protocols, Reports, and Summary sheets to review analytical raw data and reports for compliance, correctness, and completeness.
• Coordinate with Analytical Development to ensure timely availability of prerequisites required for validation and address discrepancies observed during validation/verification/transfer.
• Ensure resources (chemicals, reagents, analytical columns, standards, documents, instruments, equipment) are available to support smooth operations.
• Perform tasks assigned by the supervisor/HOD as required.
• Provide support for QC as required.
• Adherence to GLP and Health, Safety, and Environment systems in the laboratory.
• Maintain good written and communication skills.

Qualifications & Pre-Requisites

• Bachelor or Master Degree in Science or Pharmacy.
• Experience in analytical data review and knowledge of chemical analysis and instrumental analysis (HPLC/GC/UV/IC/IR/KF/Dissolution).
• Experience handling, initiating, executing, and approving incidences, investigations, file notes, ratification, OOS, OOT, Change Control, Deviations, and CAPA; responsible for GLP activities.
• Experience in US-FDA/MHRA approved companies is preferable.
• Knowledge of Empower software (Waters HPLC) is an added advantage.
• Ability to achieve deliverables with minimal supervision.

Additional Notes

• Role is expected to work in all shifts.
• If required, readiness to travel to all plant locations on work priority as per company policy.
• Responsible for compliance with GLP, Health, Safety and Environment requirements.