Lead Quality, HCM

ACG World; Mumbai Suburban; On-site; INR 800,000 - 1,300,000; Full time

Job summary

ACG World in Mumbai seeks a QA/QC leader to drive the quality strategy across manufacturing processes, ensure GMP compliance, and lead CAPA workflows.

You will review URS, approve materials, mentor engineers, manage budget, and report KPI dashboards to senior management, with focus on regulatory readiness and continuous improvement.

Qualifications

• Knowledge of QMS and GMP requirements.
• Experience in batch manufacturing records (BMR) review and batch release.

Responsibilities

• Drive start-to-end quality strategy, regulatory compliance, process reliability, and continuous improvement across the manufacturing lifecycle.
• Approve URS of each machine to complete customer compliance.
• Conduct FAT with the customers (Domestic / Export) to get acceptance before delivery.
• Approve or reject non-conforming materials and enforce CAPA workflows to resolve production defects.
• Mentor, train, and evaluate QA/QC engineers and floor inspectors.
• Manage the department budget, quality lab equipment calibration, and testing instrument upkeep.
• Communicate quality performance dashboards and KPI reports to senior management.
• Launching new products after thorough validation and field trial.

Skills

QA/QC

GMP

CAPA

Documentation

Problem solving

Education

B.Pharm

Tools

SAP

ERP

Job description

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ACG is the world’s only integrated pharma manufacturing solutions company. We are headquartered in Mumbai , India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems.

We have an opportunity in ACG Capsule / ACG Engineering / ACG Pharma Packaging / ACG Inspection.

Job Objective

Responsible for ensuring that the products produced meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to within HCM BU.

Primary responsibilities

• Drive start-to-end quality strategy, regulatory compliance, process reliability, and continuous improvement across the manufacturing lifecycle.
• Approve URS of each machine to complete customer compliance,
• Conduct FAT with the customers (Domestic / Export) to get acceptance before delivery.
• Approve or reject non-conforming materials and enforce root cause analysis (5 Whys, Ishikawa/Fishbone diagrams) & Manage Corrective and Preventive Action (CAPA) workflows to resolve production defects
• Mentor, train, and evaluate the performance of QA/QC engineers and floor inspectors.
• Manage the department budget, quality lab equipment calibration, and testing instrument upkeep.
• Communicate quality performance dashboards and KPI reports to senior management
• Launching new products after thorough validation and field trial
• Trials with formulations requiring major modification of formula / machine design
• Documentation of QA Analysis
• Assure quality flow well executed in assembly stages
• CAPA for issues reported from the market
• Conduct FAT with the customers (Domestic / Export) to get the acceptance before delivery
• Work with design for chip less assembly of the machine

Key Result Areas

• Participate in New Product Introduction (NPI) and validation.
• Training to customers, service engineers, and non-technical staff.
• Technical support to customers/ service engineers.
• Stabilization of existing products in the field.
• Modernization of quality assurance department.
• Trials with formulations requiring major modification of formula / machine design.
• Oversee incoming raw material inspection, in-process assembly checks, and final outgoing product testing.
• Establish quality benchmarks and raw material specifications for external vendors and suppliers.
• Conduct supplier quality audits and track vendor performance ratings.
• Investigate customer complaints, lead technical reviews, and respond directly to customer audit findings

Key Interfaces

Internal Interfaces

External Interfaces

• Marketing
• Regulatory Affairs Department
• Central Quality Assurance (CQA)
• Central it , sap
• Vendors and Service Providers
• Regulatory Authorities / Regulatory Bodies
• Customer Auditors
• External Auditors
• Consultants / External Agencies, as applicable
• Contract Manufacturers / Business Partners, as applicable

ACG Persona

Builder

3

Knowledge of QMS and GMP requirements

3

3

Knowledge of Batch Manufacturing Record (BMR) review and batch release requirements

4

Integrator

3

Knowledge of statutory and regulatory requirements

3

Partner

3

Knowledge of Qualification and Validation requirements

3

Nurturer

3

Knowledge of government applications such as EIA, AQCS and AHC

4

3

Knowledge of Good Documentation Practices (GDP) and Data Integrity

3

Audit and inspection handling skills

3

Problem-solving and troubleshooting skills

3

Analytical and decision-making skills

3

Training and presentation skills

3

Good interpersonal and communication skills

3

Documentation and report preparation skills

4

Knowledge of APQR and quality review requirements

4

Knowledge of regulatory submissions and compliance documentation