Manager QMS

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

Job summary

ImmunoACT is seeking an experienced Facility Operations leader to oversee Engineering, QA, and site infrastructure for GMP-regulated facilities in India. You will drive equipment qualification, preventive maintenance, validation, and documentation readiness in line with cGMP and CDSCO rules.

The role requires a strong background in facility management, QA processes, and CAPEX/OPEX oversight, with at least 10 years in GMP environments.

Qualifications

• Graduate or postgraduate degree in Pharmacy, Biotechnology, Engineering or related discipline.
• Minimum 10 years of relevant professional experience, with GMP-regulated facilities.

Responsibilities

• Lead and manage the Engineering team, ensuring efficient execution of engineering and facility operations.
• Support equipment selection, qualification, preventive and breakdown maintenance, and calibration of equipment and instruments.
• Oversee facility validation and ensure documentation readiness in accordance with cGMP requirements and applicable CDSCO regulations.
• Streamline laboratory and manufacturing facility operations.
• Manage autoclaves, gowning systems and facility consumables.
• Oversee facility qualification, housekeeping, cleaning, disinfection and hygiene management.
• Ensure effective gowning management, washing and sterilization of relevant materials.
• Manage the proper disposal of biomedical waste in compliance with applicable government regulations.
• Oversee QMS documentation and document control activities.
• Lead the preparation, review, revision and implementation of SOPs.
• Ensure GMP documentation and GDP compliance.
• Manage CAPA, deviations, change controls and audit-related documentation.
• Oversee facility and engineering operations.
• Ensure proper management and documentation of HVAC, BMS, EMS, utilities and cleanroom operations.
• Maintain preventive and corrective maintenance records.
• Ensure GMP compliance and readiness for regulatory inspections and audits.
• Coordinate with QA, Engineering, Validation and Operations teams.
• Actively participate in site selection and land procurement activities.
• Ensure adherence to health, safety, quality and environmental standards across the facility.
• Oversee EHS requirements for the plant and employees, ensuring regulatory compliance.
• Lead CAPEX procurement activities related to manufacturing, RD and projects.
• Monitor and control OPEX for maintenance and utilities.

Skills

Engineering management

Facility management

CAPEX procurement

Education

Graduate or postgraduate degree in Pharmacy, Biotechnology, Engineering

Job description

Facility Operations

Roles Responsibilities

1. Engineering and Facility Management

• Lead and manage the Engineering team, ensuring efficient execution of engineering and facility operations.
• Support equipment selection, qualification, preventive and breakdown maintenance, and calibration of equipment and instruments.
• Oversee facility validation and ensure documentation readiness in accordance with cGMP requirements and applicable CDSCO regulations.
• Streamline laboratory and manufacturing facility operations.
• Manage autoclaves, gowning systems and facility consumables.
• Oversee facility qualification, housekeeping, cleaning, disinfection and hygiene management.
• Ensure effective gowning management, washing and sterilization of relevant materials.
• Manage the proper disposal of biomedical waste in compliance with applicable government regulations.

2. Quality Management System (QMS) Documentation, Facility Operations

• Oversee QMS documentation and document control activities.
• Lead the preparation, review, revision and implementation of Standard Operating Procedures (SOPs).
• Ensure compliance with Good Manufacturing Practices (GMP) documentation and Good Documentation Practices (GDP).
• Manage Corrective and Preventive Actions (CAPA), deviations, change controls and audit-related documentation.
• Oversee facility and engineering operations.
• Ensure proper management and documentation of Heating, Ventilation and Air Conditioning (HVAC), Building Management Systems (BMS), Environmental Monitoring Systems (EMS), utilities and cleanroom operations.
• Maintain preventive and corrective maintenance records.
• Ensure GMP compliance and readiness for regulatory inspections and audits.
• Coordinate with Quality Assurance (QA), Engineering, Validation and Operations teams.

3. Project, Site Infrastructure Management

• Actively participate in site selection and land procurement activities.
• Ensure adherence to health, safety, quality and environmental standards across the facility.
• Oversee Environment, Health and Safety (EHS) requirements for the plant and employees, ensuring compliance with applicable cGMP procedures.
• Lead Capital Expenditure (CAPEX) procurement activities related to manufacturing, Research Development (RD) and projects.
• Monitor and control Operational Expenditure (OPEX) associated with maintenance and utility operations.
• Undertake any other responsibilities assigned by Management as required.

Qualifications and Educational Requirements

• Graduate or postgraduate degree, preferably in Pharmacy, Biotechnology, Engineering or a related discipline.
• Minimum 10 years of relevant professional experience, with mandatory experience in GMP-regulated facilities.