Senior Quality Auditor II

PAI Holdings LLC•Greenville, SC

About The Position

This position ensures quality and compliance to cGMPs, internal, external and international requirements with respect to Supplier Qualification. Responsibilities include maintaining current supplier qualification documentation which included SAQs , Quality Agreements, Certifications, Risk Evaluations, Audit Reports, and CAPA responses. This position be responsible for maintaining a comprehensive risk evaluation of Suppliers and determine criticality based on a risk assessment. Based on agreement of risk, onsite audits and/or SAQ documentation will be determined and maintained on a yearly basis. Travel and auditing of Critical Suppliers or Suppliers for cause will be required as part of this position

Requirements

Bachelors’ degree or equivalent years of experience, preferably in the Pharmaceutical industry.
Microsoft suite software is required, knowledge of electronic document/training systems and GMP documentation is preferred.
Strong oral and written communication skills, good analytical ability and problem-solving skills.
Critical thinking application, Attentiveness to details and deadlines with the ability to prioritize work effectively.
Flexibility to operate, and self-driven to excel, in a fast-paced environment.
Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another.
Strong Microsoft skill set, to include documentation formatting, Adobe application an Signature workflow process.
Must be able to travel a minimum 50% of the time.
Must have a valid Passport and be able to travel internationally.

Responsibilities

Knowledge and promotion of cGMP/GDP compliance in an FDA regulated pharmaceutical manufacturing environment ensuring product integrity, safety, and compliance as applies to Suppliers.
Proficiency in auditing techniques to evaluate the state of compliance of a Supplier.
Participates in site audits as part of a team, auditing of manufacturers of facilities that are used to purchase pharmaceutical ingredients, components or contract manufacturing suppling or testing product.
Knowledgeable of quality control/ microbial techniques, data integrity, ALCOA, interpretation of documentation, processes, investigations, to include all quality systems that support the Supplier to provide a product that is acceptable for use in pharmaceuticals applications.
Providing technical expertise regarding in-process contamination control.
Evaluate data and /or lab work from audit of CMO and Suppliers to assess compliance of quality system regulations (ISO,GMP, Annex I, and GLP) and SOPS.
Review records for accuracy, consistency, and compliance of aseptic processes. (During audit or documents sent in advance of scheduled audits.)
Review returned Supplier Qualification Documents to verify that documents are ready for Supplier Qualification Department Head final review and approval.
Complete a report of findings during the audit that will be a part of the final report to be discussed as part of the closing of an audit as critical, major or minor.
Follow up on audits as a result of investigations of noncompliant issues found during audits until resolution has been communicated.