Asst General Manager - Analytical Method Validation

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.