The QA/QC Manager will be responsible for establishing, implementing, and maintaining robust quality systems to ensure compliance with applicable regulatory standards such as FDA guidelines, ISO 9001, EXCiPACT and ICH requirements
Job Summary
The QA/QC Manager will be responsible for establishing, implementing, and maintaining robust quality systems to ensure compliance with applicable regulatory standards such as FDA guidelines, ISO 9001, EXCiPACT and ICH requirements.
Key responsibilities include developing and maintaining the Quality Management System (QMS), overseeing QC laboratory operations, ensuring compliance with regulatory requirements, and leading the QA/QC team.
Ashland offers a dynamic and challenging environment with competitive salary and benefits, pay-for-performance incentive plans, and opportunities for development and advancement.
Matching Summary
The QA/QC Manager will be responsible for establishing, implementing, and maintaining robust quality systems to ensure compliance with applicable regulatory standards such as FDA guidelines, ISO 9001, EXCiPACT and ICH requirements.
Skills & Requirements
Must-have
Quality Management System (QMS)
GMP, GLP, and regulatory compliance
Analytical techniques (HPLC, UV)
Vendor qualification and raw material approval
Internal audits and regulatory inspections
Data integrity principles (ALCOA+)
Nice-to-have
Continuous improvement
Inspired and engaged employees
Dynamic and challenging environment
Integrity and honesty
Key Requirements
10–15 years in pharmaceutical / excipient manufacturing