Senior Auditor, Audit Management
Company: CSL Behring
Location: Holly Springs
Posted on: May 15, 2022
Job Description:
Job DescriptionJob Purpose: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.Major Accountabilities:
- 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
internallyMinimum Requirements:
- Bachelor's degree in science or engineering discipline Advanced
degree is preferred.
- Minimum of 3 years of engineering, manufacturing, or quality
experience in regulated industry, biotech/pharmaceutical industries
preferred. years of experience preferred.About UsOur
BenefitsSeqirus is committed to attracting and retaining
world-class employees who are valued for their contributions to
achieving business objectives. Learn more about some of the
benefits you can participate in when you join Seqirus.About
SeqirusSeqirus is part of CSL Limited (ASX: CSL). As one of the
largest influenza vaccine providers in the world, Seqirus is a
major contributor to the prevention of influenza globally and a
transcontinental partner in pandemic preparedness. Learn more about
Seqirus .We want Seqirus to reflect the world around usAs a global
organisation with employees in 35+ countries, CSL embraces
diversity, equity and inclusion. Learn more about Diversity, Equity
& Inclusion at Seqirus.Do work that matters at Seqirus!
Keywords: CSL Behring, Cary , Senior Auditor, Audit Management, Executive , Holly Springs, North Carolina
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