Consutlant
Aequor JD ·www.aequor.com
Apply direct The purpose of this scope of work is to support global Manufacturing site and systems compliance assessment and improvement plan development and execution. The scope of work includes consulting services, review of internal procedures and documentation, development of assessment summaries and recommendations, support of plan execution working with internal manufacturing and quality staff.
- Perform comprehensive assessments of Regulatory Inspection readiness and cGMP Compliance, with specific focus on unannounced FDA inspections, of Global manufacturing sites.
- Provide Inspection preparation and support as needed
- Provide support for responding to Regulatory Information Requests and FDA and Global Health Authority Inspection Observations and follow-up as needed
- Provide Manufacturing Site, Network and Quality Systems evaluations for process, program and site improvement as needed. Develop plans partnering with internal staff and monitor plans through completion.
- Implement an enterprise-wide inspection management and compliance readiness system that provides executive and site management with clear line of sight to top compliance risks and resolution plans/status, as well as base process and procedure overview presentations and playbooks in preparation for global Health Authority inspections. This system also provides linkages to corporate, enterprise-level governing documents and business processes, quality system elements and teams. This connectivity is critical to be aligned with each site in the operations network and a conduit for internal compliance and quality, operations staff to assess internal processes against HealthCare Client Authority guidance, regulatory inspection trends and findings in order to drive pro-active applicability assessments and risk reduction actions within company . This proven system will drive a systematic approach to 365 days a year inspection readiness and drive continuous improvement across the business leading to a higher state of compliance and quality, value for patients and the company.
- Assess internal Quality Compliance processes and recommend strengthening, collaboration and harmonization elements to drive the organization forward partnering with key stakeholders within corporate and site management.
- Partner with Operations Strategy to develop and implement operational improvements, perform internal and external site and business process assessments as needed, drive standard work and work-management business and compliance systems implementations resulting from assessments and Operations Strategy goals and objectives.
Frequently asked questions
Who is hiring for the Consutlant role?
Aequor JD is hiring for the Consutlant position, a Shazamme client. Apply directly on the employer's career site.
Where is the Consutlant job located?
The Consutlant role with Aequor JD is based in US.
What does the Consutlant role pay?
Aequor JD lists the Consutlant role at up to USD 275 per month.
Is the Consutlant role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Consutlant role?
The Consutlant position is aimed at mid-level candidates.
How do I apply for the Consutlant role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.