Specialist - Facility & Operations

1. Role Title:

Specialist - Facility & Operations

2. Department/Function:

Facilities & Operations - Technical Operations & Inventory

3. Reporting Structure:

Reports to: Technical Operations and Inventory

Direct Reports: Individual contributor

4. Role Summary:

This position must implement and execute the operating guidelines for the cleanroom facility. It should also be able to manage technical operations by anticipating demand and arranging the supply of all cleanroom requirements. Implement the strategy to keep the clean rooms operationally sound and maintain the standards for smooth operations. The person should act as a SPOC for all operational activities related to all labs and activities. The role shall enable the smooth functioning of all the labs and improve existing systems and processes to make them more efficient and compliant

5. Key Responsibilities:

• Managing day-to-day site operations for all the labs
• Supervise and direct on-site instrument and equipment Calibration and qualification.
• Generate and review GMP documentation such as Standard Operating Procedures, non-conformance reports, deviations, CAPA, cleaning records, temperature monitoring and updates to the reporting manager
• Verification of all the annexures generated by the lab technicians like, cleaning record, temperature monitoring
• Liaising between internal stakeholders and vendors for calibration/ AMC/ breakdown, and maintenance of instruments
• Work with Quality & Compliance to ensure all-time Audit readiness from a Lab & MFG perspective
• Improve operational management systems, processes, and best practices
• PR creation for all the instrument AMC and utility vendors
• Coordinating with utility vendors for the timely delivery of materials like liquid nitrogen, gas cylinders.
• Recording and disposing of Biomedical waste
• Perform routine stock checks to maintain levels of critical stock consumables, restock gowning garments, and critical consumables in the clean area as required.
• Supervising lab technicians in their day-to-day activities
• Provide training and mentoring to ensure a good understanding of the tasks allocated to the lab technician.
• Drive R&D Lab & Equipment procurement, maintenance & management
• Support R&D sample management and act as a SPOC for clinical samples received for R&D purposes.
• Support R&D procurement activities to consolidate orders to enable cost savings

6. Competencies Required:

1. Should have an understanding of how IQ/OQ/PQ for instruments and documentations are associated with the same.
2. GMP documentation
3. Clean room practices
4. Operations in the ERP system (SAP)
5. Material inspection

• Soft Skills:

1. Basic IT skills. Expert with MS Office (Excel, Word).
2. Good communication skills.
3. Team player & Collaborative
4. Resourceful & Quality commitment
5. Detail-oriented & Strategic thinker
6. Enthusiastic & Committed

7. Qualifications:

1. Minimum Bachelor's degree in Science, Eight+ years of related experience in relevant areas of lab operation and clean room area in pharmaceutical, working effectively and collaboratively across departments and functions. Prior experience working with GMP systems.

8. Working Conditions:

• Role Type: Full Time and Onsite
• Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday
• Travel Requirements: Occasional, as required for business needs
• Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore -