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Job duties/responsibilities
- Review and approval on change controls, deviations, investigations, and CAPAs.
- Lead the establishment and maintenance of Quality Agreements.
- Provide quality advice and oversight on validation/compliance strategies.
- Review and approval of SDLC deliverables.
- Review and approval of SOPs, Work Instructions, User Guides, Role Matrices.
- Approve vendor qualification documents such as questionnaires, audit reports, and audit responses.
Requirements
- Bachelor’s/ Master’s degree or equivalent in a scientific or health care field.
- 2-5 years experience as a Quality Consultant in the pharmaceutical/Life sciences industry preferred.
- Independent, self-motivated, and results driven.
- Willing & able to quickly acquire new technical skills & business principles.
- A critical thinker with logical reasoning.
- Curious and always looking for creative solutions to complex problems.
Benefits
- Competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
