Beschreibung

As a QA Manufacturing Specialist, you will ensure product quality by monitoring manufacturing processes, conducting audits, and providing on-the-floor training. This role involves real-time oversight, documentation review, and supporting compliance with GMP standards.

Anforderungen

• •Strong background in quality assurance within pharmaceutical or regulated manufacturing environment
• •Solid understanding of GMP (Good Manufacturing Practices)
• •Good understanding of aseptic process and its core requirements
• •Excellent communication and coaching skills
• •Ability to make sound decisions and manage deviations in a fast-paced setting
• •Collaborative spirit and passion for ensuring compliance and product integrity

Aufgaben

• •Perform real-time quality assurance support on the shop floor
• •Monitor adherence to GMP practices during critical manufacturing steps
• •Witness and verify critical process steps and in-process controls
• •Document line clearances before manufacturing operations
• •Review manufacturing processes for compliance with batch records and SOPs
• •Ensure proper material handling, labeling, and segregation during production
• •Identify and report deviations or abnormal events on the shop floor
• •Support or lead impact assessment and documentation of deviations
• •Coordinate with QA and production leadership for timely resolution
• •Review completed batch manufacturing records for accuracy and compliance
• •Assist operators with proper GMP documentation practices
• •Verify logbooks, equipment use records, and cleaning records
• •Observe interventions during aseptic operations for compliance
• •Support environmental monitoring and cleanroom behavior compliance
• •Conduct routine walkthroughs and spot checks for GMP standards
• •Participate in internal audits and regulatory inspections
• •Provide on-the-job coaching and GMP guidance to operators
• •Reinforce good documentation practices and quality culture
• •Provide input into root cause analysis based on observations
• •Support implementation of corrective and preventive actions

Benefits