Job Description
Position Overview
We are seeking a Change Control Specialist to support regulated pharmaceutical manufacturing operations by managing change control activities in compliance with c GMP and global regulatory standards. The role will partner closely with Quality, Manufacturing, Validation, and Engineering teams to ensure changes are assessed, implemented, and closed effectively.
Key Responsibilities
Manage the complete change control lifecycle, including initiation, impact assessment, approval, implementation, and closure
Conduct cross-functional impact assessments across quality, manufacturing, validation, and regulatory areas
Ensure compliance with c GMP requirements and FDA regulations, including 21 CFR Parts 210 and 211
Maintain accurate and inspection-ready documentation within electronic quality systems
Support internal, customer, and regulatory audits related to change management
Qualifications & Experience
3–7 years of experience in pharmaceutical manuf...
We are seeking a Change Control Specialist to support regulated pharmaceutical manufacturing operations by managing change control activities in compliance with c GMP and global regulatory standards. The role will partner closely with Quality, Manufacturing, Validation, and Engineering teams to ensure changes are assessed, implemented, and closed effectively.
Key Responsibilities
Manage the complete change control lifecycle, including initiation, impact assessment, approval, implementation, and closure
Conduct cross-functional impact assessments across quality, manufacturing, validation, and regulatory areas
Ensure compliance with c GMP requirements and FDA regulations, including 21 CFR Parts 210 and 211
Maintain accurate and inspection-ready documentation within electronic quality systems
Support internal, customer, and regulatory audits related to change management
Qualifications & Experience
3–7 years of experience in pharmaceutical manuf...
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