• Act as the Quality Assurance site subject matter expert for all questions and issues related to incoming
release and SAP utilization for release activities, to include:
o Key contact for internal departments and other sites, receive information and distribute as appropriate.
o Become the site leader in the technology – attend conferences, develop technical expertise, conduct onsite training, etc.
o Act as the site consultant when issues arise.
o Assist with project definition during design of projects and project effectiveness review post implementation.
• Be owner for local SOPs on release and sampling of purchased materials as well as QA approver / authority for SOPs relating to WHS receipt, ensuring –
o Compliance with CFR requirements and GSK higher level documents.
o Consistent use of SAP across QA Incoming Release WHS departments from different sites
o Clear traceability, visibility and accuracy of decision making processes
• Ensure accurate and timely release of purchased lots within SAP by:
o Timely closure of QA Inspection Plans
o Ensuring consistent data packs for release – verifying completeness of documentation - challenging variations in SAP data or presentation – always ensuring 100% clarity on release of a lot.
Knowledge/ Education / Previous Experience Required:
• BS or BA in Microbiology, Biochemestry, Chemical Engeneering or relevant technical discipline. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
• Minimum of 5 years pharmaceutical industry experience with ≥ 2
years in licensed biopharmaceutical or biological products.
• Minimum of 2 years in quality organization.
• Strong SAP knowledge
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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