Lead Quality, HCM

Position Title:

Lead QA/QC - HCM

Employee Name:

Grade:

M06/M07/M08

Department:

Quality

Location:

HCM Kandivali

Reports to:

Glen Godinho

Reported by:

Technician – QA/QC

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.

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.

• 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

Internal Interfaces

External Interfaces

• All Plant-level Functions(all dept names

• Sales & Customer Service (CSR)
• 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

Persona

Level

Competency

Level

Builder

3

Knowledge of QMS and GMP requirements

3

Innovator

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

Entrepreneur

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

4

Minimum Requirement

Desired

Level of Education

• BE – Mechanical

• ME – Mechanical

Experience

• 8 – 10 Years

• 4 – 6 Years