Job: Specialist/Sr. Specialist (Auditor), Seqirus, Holly Springs, NC
Specialist/Sr. Specialist (Auditor)
Holly Springs, NC 27540 United States
Manufacturing and Production
Responsible for the aspects of GMP/GxP audits of vendors, internal sites, and contract manufacturers, assessing compliance with regulatory and Seqirus requirements, to provide quality oversight and guidance to identify quality risks, assess severity, and facilitate appropriate mitigations to ensure compliance and continuous improvement at each of the manufacturing sites.
This individual is also responsible to support the harmonization, maintain and enforcing global audit strategy, processes, practices, and SOPs that are consistent across the manufacturing sites.
Provides support for the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirements
Support to develop quality policies, procedures and standards governing and harmonizing of the global audit and inspection program for all Seqirus sites.
Assist in the development of a global audit program and schedule in collaboration with other sites.
Ensure that all audits and inspections are performed as per plan (either internally or by a 3rd party contractor).
Assist to co-ordinate and execute supplier audits including inspections of CMOs/ Vendors/ distributors/ laboratories and service providers
Participates and Support in Regulatory inspections at Seqirus sites
Provide support and subject matter expertise to manufacturing sites, clinical sites and CMOs in preparation for regulatory inspections
Participate in inspections to understand root causes behind quality issues
Communicate identified quality issues globally to avoid repeated issues
Track inspection responses and commitments to Regulatory agencies (Health authorities) across at assigned site.
Maintain processes, procedures, and SOPs for auditing and inspections
Partner with stakeholders to assist to develop and communicate innovative, compliant solutions using a risk based approach for internal and external inspections
Support the global model for corporate audits (bi-annually) to identify weakness in cGMP systems.
Support to develop in principles of auditing and inspections.
Ensure to upkeep accreditation, qualification to perform required inspections and adhere to processes and SOPs ensure inspectors are trained and accredited
Maintain and update processes, procedures, and SOPs based on continuous improvement for conducting both internal and external audits
Maintain and share knowledge of Regulations and Requirements
Stay current and up to date with any regulations and requirements related to audit management as well as industry/regulatory trends in this area
Identify and/or create new requirements for Seqirus to ensure a high level of quality; communicate new Seqirus requirements internally
Bachelor's degree in science or engineering discipline Advanced degree is preferred.
Minimum of 1 year of engineering, manufacturing, or quality experience in regulated industry, biotech/pharmaceutical industries preferred. 3 years of experience preferred.
ASQ (American Society of Quality) certifications desired
Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations required
Demonstrated ability to interact with and gain the support of senior management, global partners, and cross functional teams
In depth knowledge of the regulatory environment for the manufacture of drugs
Must possess thorough knowledge of global cGMP regulations and ISO standards
Demonstrated ability to understand data sets and drive to data-based decisions
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