SUMMARY:
The GMP Auditor will be responsible for performing Quality System and GMP compliance Audits of Suppliers and Vendors in the Pharmaceutical manufacturing. Compliance with applicable regulatory guidelines and requirements is critical for our clients, and our QS Auditors are key to ensuring that we meet these expectations. This role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent. Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
JOB RESPONSIBILITIES:
- Pharmaceutical or related manufacturing processes and be thoroughly familiar GMP/cGMP regulations (e.g. FDA cGMPs, JCH, ISO, WHO, IPEC).
- Conducts audits at CMO, testing, packaging, and warehouse/distribution.
- Conducts audits to agreed time frames including CAPA Management.
- Reviews documentation for tech transfer and validation of analytical methods and manufacturing processes.
- Determines Compliance Risk for vendors/contractors.
- Create and drive the execution of the internal audit.
- Audit SOP(s) to ensure contents meet regulatory requirements and interpretations.
- Audit records and reports to ensure they accurately reflect the protocols, SOP(s), production records, procedures and actual data results obtained during GMP.
- Identify noncompliance and deviations, while recommending corrective and preventative actions in an educational and persuasive manner.
- Issue audit reports to disclose noncompliant findings to Management and verify their follow-up responses are adequate and complete to close the audit.
- Support with client and regulatory audits or any department goals as requested by supervisor or manager.
- Support the creation of quality agreements.
- Address Supplier Change Notifications and impact assessment on GMP.
- Supports the supplier qualification programs.
- Demonstrates strong understanding of procedures and method for review function.
- May participate on client project teams.
- Actively participates in cross-functional compliance improvement projects.
- Demonstrates a strong understanding of how systems interrelate.
- Demonstrated ability to multi-task and work on several QA projects and problems.
- Can deduce next steps on problems with minimal direct supervision.
- Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
- Other duties as assigned.
REQUIRED SKILLS AND EXPERIENCE:
- BS in Chemistry, Biology or other relevant discipline or equivalent work experience
- 4-6 years QA or related experience working in a regulatory environment or position (GLP,GCP or GMP).
- Strong understanding of cGMP's and concepts in several quality systems.
- Understanding of basic scientific/technical concepts.
- Good analytical skills.
- Clear, concise writing skills.
- Good verbal presentation skills.
- Excellent organizational skills and attention to detail.
SPECTRUM PHARMACEUTICALS is an equal opportunity employer, we evaluate qualified applicants without regard to race, color. Religion, sex, national origin, disability, veteran status, and other protected characteristics.
Required Skills
Required Experience