QA manager’s Job Description:
- Responsible for the implementation and maintenance of QA documentation systems to meet regulatory and cGMP requirements for drug product manufactured from early phase, BE study, through Product launch and subsequent distribution.
- Enhance and maintain the controlled document system for standard operating procedure, batch records and quality standards.
- Partner with ITs to implement necessary QA documentation electronic systems.
- Create, modify and maintain system to track and improve the document approval cycle.
- Provide technical writing support and training for all functional groups.
- Participate in cross-functional teams as necessary.
- Ensure appropriate management of documentation.
- Knowledge of DSCSA and SAP is preferable.
- Bachelor’s degree in scientific discipline, with minimum 4-5 years of experience in Pharmaceutical or Biotechnology Industry.
- Experience in Quality systems with emphasis on technical writing and documentation.
- Strong knowledge of FDA’s cGMP and ICH Guidelines.
- Strong writing and verbal communication skills in English.
- Author, review and approve SOPs and other controlled documentation for compliance with applicable regulations.
- Good organizational and interpersonal skills and the ability to work under pressure.
- Working experience and knowledge of Microsoft Office is necessary.
Please mail your resume to HR at 2002 Eastpark Blvd., Cranbury NJ 08512