Yochana
Senior Technical Recruiter at E‑Solutions
Responsibilities
Support continuous improvement by participating in deviation investigations, CAPA management, and change control.
Perform quality assurance oversight for manufacturing operations and support GMP compliance.
Lead and participate in Quality Management Reviews (QMR) to analyze key quality metrics such as deviations, CAPAs, audit findings, and complaints.
Collaborate cross‑functionally with Quality, Manufacturing, Validation, and Regulatory teams.
Qualifications
Experience supporting cGMP manufacturing operations especially for therapies like cell therapy through administration and enforcement of the Quality Management System.
Working knowledge of cGMP/ICH/FDA/EU regulations and experience in US and international regulations.
Direct experience reviewing and/or authoring Standard Operating Procedures (SOPs).
Excellent oral and written communication skills with technical writing experience required.
Contribute for conduct of thorough investigations like OOS/OOE, OOT & RCA studies.
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Support continuous improvement by participating in deviation investigations, CAPA management, and change control.
Perform quality assurance oversight for manufacturing operations and support GMP compliance.
Lead and participate in Quality Management Reviews (QMR) to analyze key quality metrics such as deviations, CAPAs, audit findings, and complaints.
Collaborate cross‑functionally with Quality, Manufacturing, Validation, and Regulatory teams.
Qualifications
Experience supporting cGMP manufacturing operations especially for therapies like cell therapy through administration and enforcement of the Quality Management System.
Working knowledge of cGMP/ICH/FDA/EU regulations and experience in US and international regulations.
Direct experience reviewing and/or authoring Standard Operating Procedures (SOPs).
Excellent oral and written communication skills with technical writing experience required.
Contribute for conduct of thorough investigations like OOS/OOE, OOT & RCA studies.
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr