Asst. Manager / Manager – Section Head (Validation / Qualification / CSV)

SAVA Group; Indor; On-site; INR 900,000 - 1,300,000; Full time

Job summary

SAVA Group is seeking a quality assurance professional to supervise and execute validation activities across equipment, utilities, and areas at the site. You will prepare and review SOPs, protocols, reports, and master validation plans, ensuring compliance with cGMP standards.

Responsibilities include process validation, hold time studies, cleaning validation, thermal mapping, and implementation of computer systems validation and QMS elements.

Responsibilities

• Primary: Responsible for review and execution of all validation & qualification activities at site pertaining to equipment's, utilities and area qualification.
• Primary: Responsible for preparation and review of Standard Operating Procedure, protocols & reports, Validation master plan, Site master file, Quality manuals etc.
• Primary: Responsible for execution of process validation, hold time studies, cleaning validation and other miscellaneous validation activities.
• Primary: Responsible for execution of thermal mapping and Transport validation studies.
• Primary: Responsible for preparing and effective implementation of SOP for handling of outside service providing agencies.
• Primary: Responsible for effective implementation of computer system validation, ALCOA+++ principle, Learning management system, Quality risk management, Quality management system.
• Primary: Lead and supervise cross-functional teams in Quality Assurance, Microbiology and Quality control.
• Primary: Assign tasks, monitor performance to ensure departmental goals are met.
• Secondary: Responsible for implementation and ensuring effectiveness of Quality Management System at site pertaining to CAPA, Change control, Quality events, QRM etc.
• Secondary: Responsible for providing resources and guidance to executives, officers to carry out their job responsibilities.
• Secondary: Coordination with production for the preparation, review and issuance of Batch manufacturing record, Batch packing record.
• Secondary: Responsible for line clearance activities as per the approved batch manufacturing record.
• Secondary: Responsible for review and identification of gaps in procedure and practices against cGMP requirements.

Job description

Key Responsibilities & Accountability – Handled Individually

• Responsible for review and execution of all validation & qualification activities at site pertaining to equipment's, utilities and area qualification.
• Responsible for preparation and review of Standard Operating Procedure, protocols & reports, Validation master plan, Site master file, Quality manuals etc.
• Responsible for execution of process validation, hold time studies, cleaning validation and other miscellaneous validation activities as and when required.
• Responsible for execution of thermal mapping and Transport validation studies.
• Responsible for preparing and effective implementation of SOP for handling of outside service providing agencies.
• Responsible for effective implementation of computer system validation, ALCOA+++ principle, Learning management system, Quality risk management, Quality management system.
• Lead and supervise cross-functional teams in Quality Assurance, Microbiology and Quality control.
• Assign tasks, monitor performance to ensure departmental goals are met.

Secondary Responsibilities

• Responsible for implementation and ensuring effectiveness of Quality Management System at site pertaining to CAPA, Change control, Quality events, QRM etc.
• Responsible for providing resources and guidance to executives, officers to carry out their job responsibilities.
• Coordination with production for the preparation, review and issuance of Batch manufacturing record, Batch packing record.
• Responsible for line clearance activities as per the approved batch manufacturing record.
• Responsible for review and identification of gaps in procedure and practices against cGMP requirements.