Asst General Manager - Analytical Method Validation

Rubicon Research; Mumbai, Ambernath; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Rubicon Research in Ambernath, Maharashtra, seeks a senior QC leader to drive a 40+ member department. You will back the QC HOD, oversee method validations, and ensure robust QMS governance across solid oral, nasal, and liquid lines. The role requires strategic oversight of audits and global compliance.

The candidate will manage end-to-end QC operations, supervise performance reviews, and lead digitization projects while upholding GLP, EHS, and safety standards on the lab floor.

Qualifications

• 18+ years of progressive pharma QC experience.
• Experience with Solid Oral, Nasal and Liquid dosage forms in regulated plants.
• Experience defending data during USFDA, MHRA and EU inspections.
• Strong leadership of a 40+ member QC team.
• GMP/QMS, GLP and EHS compliance knowledge.

Responsibilities

• Lead a QC department of 40+ members to meet commercial targets and site objectives.
• Provide strategic technical backup to the QC HOD and oversee daily operations and multi-site coordination.
• Oversee end-to-end execution of analytical method validations, verifications, and transfers.
• Authorize and approve critical QMS records (Incidents, Investigations, CAPAs, etc.).
• Lead laboratory automation projects from conception to rollout and digitization.
• Oversee lab infrastructure setup and compliance for new lab deployments.
• Ensure verification of raw analytical data before submission to QA/regulatory bodies.
• Lead USFDA/MHRA/EU inspections as SME.
• Implement structured problem-solving to resolve instrumental bottlenecks.
• Ensure GLP and EHS standards on the lab floor.
• Conduct monthly performance reviews and training matrices.
• Step in to manage site QC operations during absence of HOD.

Skills

Advanced instrumentation

Method lifecycle & validation

Regulatory & audit mastery

QMS & investigations

Large team management

Education

M.Sc / B.Pharm / M.Pharm

Tools

Chromeleon 7.2

Job description

Role & responsibilities

Purpose

To lead a Quality Control department of 40+ members at the Ambernath facility, driving strategic laboratory operations, automation projects, and analytical method lifecycles across Solid Oral, Nasal, and Liquid lines. This role acts as a secondary lead to back up the QC HOD, ensuring robust QMS governance and successfully defending data during major international regulatory audits.

Responsibilities

• Lead, mentor, and drive a large Quality Control department of 40+ members to meet commercial output targets and site objectives.
• Provide strategic technical backup to the QC HOD, overseeing daily operations, monthly sample statuses, and multi-site coordination.
• Direct the end-to-end execution, compliance, and timely delivery of Analytical Method Validations, verifications, and method transfers.
• Authorize, execute, and approve critical QMS records including Incidents, Investigations, File Notes, Ratifications, OOS, OOT, Change Controls, and CAPAs.
• Lead laboratory automation projects from conception to rollout, taking full ownership of technical upgrades and digitization.
• Drive engineering, installation, and compliance strategies required for setting up new pharmaceutical laboratory infrastructures.
• Oversee the verification of raw analytical data from high-end equipment before submission to QA or regulatory bodies.
• Frontface international regulatory inspections (USFDA, MHRA, EU-GMP) individually as a lead subject matter expert.
• Implement structured problem-solving mechanisms to quickly troubleshoot instrumental bottlenecks and resolve complex technical anomalies for the team.
• Enforce absolute compliance with Good Laboratory Practices (GLP) and Health, Safety, and Environment (EHS) standards on the lab floor.
• Conduct comprehensive monthly performance reviews and map out robust training matrices to enhance operational quality and team output.
• Step in to independently manage entire site QC operations during the absence of the QC HOD and execute corporate tasks delegated by senior leadership.

Required Skills

• Advanced Instrumentation Expertise: Masterful hands‑on knowledge of modern analytical instruments like HPLC, GC, IC, Dissolution, PSD, and Karl Fischer.
• Method Lifecycle & Validation: Expert capability in supervising analytical method validation, verification protocols, and cross‑site method transfers.
• Regulatory & Audit Mastery: Proven competency in leading, answering, and independently defending complex laboratory data during USFDA, MHRA, and EU inspections.
• QMS & Investigation Drive: Strong analytical capability to investigate structural lab failures, execute root cause analysis, and enforce bulletproof CAPAs.
• Large Team Management: Exceptional leadership stature, cross‑functional coordination ability, and decision‑making skills to manage a 40+ member setup.

Preferred Candidate Details

• Education & Experience: Regular Masters Degree in Science (M.Sc) or a Bachelor's/Master's in Pharmacy (B.Pharm/M.Pharm) with 18+ years of progressive pharma QC experience.
• Technical Background: Robust working exposure managing complex testing protocols for Solid Oral, Nasal, and Liquid dosage forms in highly regulated plants.
• Software Familiarity: Practical working knowledge of advanced chromatography data systems, with specific advantage given to experience in Chromeleon 7.2 software.
• Infrastructure Exposure: Past experience in actively executing new laboratory set‑ups or greenfield/brownfield lab expansion projects.
• Geographic Alignment: Candidates currently residing in or willing to permanently deploy to the Ambernath (Maharashtra) industrial manufacturing cluster.