Compliance Specialist I
Jubilant Pharma Limited
Summary
The Compliance Specialist I is responsible for regulatory compliance and quality standards within the manufacturing environment. The role manages a variety of compliance activities, including Environmental Monitoring Investigation Reports (EMRs), Environmental Deviation Reports (EDRs), TrackWise deviations, investigation tasks, and area documentation. The specialist ensures that investigations, corrective actions and related tasks are completed accurately, on time, and in alignment with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and established Service Level Agreements (SLAs).
Job description
In addition to managing documentation and investigations, the Compliance Specialist partners closely with area specialists, training specialists, and cross functional teams to support compliance initiatives, promote audit readiness, and identify opportunities for process improvement. This position requires strong attention to detail, organizational skills, and a proactive approach to driving compliance across the department, ultimately ensuring product quality, regulatory alignment, and patient safety.
Responsibilities
- Prepare and manage Environmental Monitoring Investigation Reports (EMRs), Environmental Deviation Reports (EDRs), TrackWise deviations, and investigation tasks in alignment with quality and regulatory requirements.
- Ensure timely completion of investigations, root cause analysis, and corrective/preventative actions (CAPAs) to meet established Service Level Agreements (SLAs).
- Maintain area documentation and records to ensure compliance with GMP, SOP, and applicable regulatory standards.
- Partner with area specialists, training specialists, and cross functional teams to support compliance initiatives.
- Provide manufacturing support when required.
- Identify and recommend process improvements to strengthen compliance practices and drive efficiency.
- Support audit readiness by ensuring accurate, complete, and well-maintained documentation and records.
- Perform additional compliance-related tasks and responsibilities as assigned.
Working Environment
- Respirator Clearance Required.
- Exposure to latex.
- Exposure to moderate noise levels.
- Possible contact with cleaning chemicals.
- Ability to sit or stand for extended periods of time.
- Work in a cleanroom.
Requirements
- High School Diploma or equivalent
- 2 years' manufacturing experience
- SAP
- TrackWise
- MasterControl
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Respirator clearance required
Benefits
- Medical, Dental & Vision
- FSA & HSA
- Life & AD&D Insurance
- Short-Term & Long-Term Disability
- Employee Assistance Program
- Benefits start day one
Company overview
Jubilant Pharma Limited is a global integrated pharmaceutical company headquartered in Singapore with operations spanning multiple continents. As a wholly-owned subsidiary of Jubilant Pharmova Limited, the company operates through three core business segments: Specialty Pharmaceuticals, CDMO (Contract Development and Manufacturing Organization), and Generics & APIs. The Specialty Pharmaceuticals division focuses on radiopharmaceuticals with a network of 48 radiopharmacies in the US, along with allergy immunotherapy products where it holds a 25% market share in the US allergenic extract market. The CDMO segment provides contract manufacturing services for sterile injectables and non-sterile products, while the Generics & APIs business manufactures active pharmaceutical ingredients and solid dosage formulations. With approximately 5,200 employees worldwide, Jubilant Pharma operates six manufacturing facilities serving regulated markets including the US, Europe, and other regions across over 75 countries. The company is recognized as a 'Partner of Choice' by leading pharmaceutical companies globally and maintains strong market positions in radiopharmaceuticals, allergy therapy products, and several key generic formulations.