General Manager - QC

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

Job summary

Rubicon Research Ltd. seeks a General Manager - QC Ambernath Plant to lead the QC function and a 150+ member team at the Ambernath site in Maharashtra, India. The role demands 20+ years of experience in QC leadership for a USFDA-regulated pharmaceutical formulation facility.

Preferred qualifications include MSc/M.Pharm, strong expertise in HPLC, GC and method validation, and oversight of OOS, CAPA and QMS. Solid knowledge of LIMS, SAP and Empower is desirable.

Qualifications

• Lead the QC function and 150+ member team.
• Ensure GMP/GLP/ICH/USFDA/EU compliance across the laboratory.
• Deep expertise in analytical techniques including HPLC, GC, UV, IR and DSC.

Responsibilities

• Lead the overall QC function and 150+ member team.
• Manage testing of RM, PM, in-process and finished products with method validation and transfer.
• Ensure laboratory compliance with GMP, GLP, ICH, USFDA, MHRA and EU requirements.
• Drive QC planning, sample management, KPI tracking and continuous improvement.
• Lead regulatory inspections/audits and ensure audit readiness.

Skills

QC Leadership

AMV

HPLC

GC

Method Validation

Method Transfer

Stability

OOS

CAPA

GMP

GLP

USFDA/EU Audits

Education

MSc / M.Pharm

Tools

LIMS

SAP

Empower

Job description

General Manager - QC Ambernath Plant

Dear Candidate,

Key Responsibilities

• Lead the overall QC function and 150+ member team, including AMV.
• Manage testing of RM, PM, in-process and finished products, including method validation, method transfer and stability studies.
• Ensure laboratory compliance with GMP, GLP, ICH, USFDA, MHRA and EU requirements.
• Strong expertise in HPLC, GC, UV, IR, DSC, PSD and other modern analytical techniques.
• Manage OOS, deviations, incidents, RCA, CAPA and laboratory QMS.
• Ensure calibration, qualification and preventive maintenance of laboratory instruments.
• Drive QC planning, sample management, laboratory productivity, KPIs and continuous improvement.
• Lead regulatory inspections/audits and ensure overall audit readiness.
• Collaborate with QA, RA, R&D, AD, Supply Chain and other stakeholders.

Key Skills

QC Leadership, OSD, AMV, HPLC, GC, Method Validation, Method Transfer, Stability, OOS, CAPA, GMP, GLP, USFDA/EU Audits, LIMS, SAP & Empower.

Preferred

Strong experience as QC Head/Site QC Head in a USFDA-regulated pharmaceutical formulation facility.

Location

Location: Ambernath

Experience

Experience: 20+ Years

Qualification

Qualification: M.Sc / M.Pharm

Dosage Form

Dosage Form: Solid Oral Dosage (Liquid/Nasal exposure is an added advantage)

Rubicon Research Ltd.