Responsibilities for the Quality Assurance Manager include:- Manage a team of quality assurance professionals within a GDA/GMP Pharmaceutical manufacturing environment.
- Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
- Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
- Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
- Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
- Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
- Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
- Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
- Review and approval of qualification activities, quality records like deviations OOS, complaints, auxiliary forms, investigations, procedures and other quality related documentation.
Qualifications for the Quality Assurance Manager Include:- A minimum of 8+ years of work experience within FDA/GMP regulated manufacturing environments
- Hands on leadership experience within pharmaceutical quality assurance
- In-depth knowledge of cGMP and regulatory requirements (US and EU) applicable to the pharmaceutical, biotechnology, or related industries.
- Bachelor's or higher degree within in Scientific field
Compensation for the Quality Assurance Manager include:- Salary Range is $115,000 - $135,000 dependent upon experience
- Comprehensive benefits package
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