No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team.
Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope & Responsibilities:
- Key equipment/systems include Architectural & building maintenance work, clean room maintenance, fire protection system, security system, painting, docks, grounds, pest control, staff amenities, janitorial, cGMP cleaning and sanitization, gowning services, etc.
- Partners with vendors, establishes KPI and perform audits for vendor service contracts and ensure the performance of outsourced services to established SLA
- Establishes and operates a customer service feedback mechanism to address and timely resolve concerns raised
- Attends SQDIP meeting or production coordination meeting where required
- Maintains facilities work order relating to routine or non-routine maintenance of facilities building maintenance
- Maintains high standards of cleanliness levels as required in various zones in compliance to QA requirements
- Coordinates and manages pest control service program and follow up closely on pest incident and investigation
- Coordinates schedules for operations, maintenance, and administrative staff on required basis for effective facilities program implementation and required enforcement
- Supervise and monitor contractor’s performance in accordance to KPI established
- Provides support in preparation of audit room & war room and ensure facility readiness for audit
- Owns facilities services related Non-Conformance (NC) and Corrective Action and Preventive Action (CAPA)
- Provides training as required and maintains all records as necessary to satisfy SOP's and GxP requirements
- Partner with EHSS to develop and manage sustainability effort
- Manages facility improvement works and supports facilities related cost saving projects
- Manages all facilities soft services, couriers, stationery, meeting rooms, café, pantry, bus services, café operations, etc.
- Participate actively in the site emergency response team and any EHS training
- Lead and manage all site activities within the plant, such as festive celebrations, making it a Great Place to Work
Qualifications:
- Master’s degree in engineering or Facilities Management OR
- Bachelor’s degree in engineering or Facilities Management and 2 years of engineering, operations or facilities experience in GMP environment OR
- Associate’s degree in engineering or Facilities Management and/or 6 years of engineering, operations or facilities experience in GMP environment OR
- High school diploma in Engineering or Facilities Management / GED and 8 years of engineering, operations or facilities experience in GMP environment
- Familiar with documentation in a highly regulated environment
- Knowledge in NC/CAPA/Change Control, engineering documentation, drawing or records management
- Experience in managing contractors and vendors
- Good interpersonal and communication skills with high computer literacy
- Strong customer service focus personalities
