Business Systems Analyst (Pharma IT Systems/GxP) – Top $$/Direct Hire
Our client, a Raleigh area pharmaceutical company with a growing portfolio of sterile drug and combination products, is actively recruiting for a very sharp Business Systems Analyst, with substantial knowledge of IT/IS systems and standards in a GMP/GLP/GCP setting, to join its top-notch team.
This role will involve designing, implementing and maintaining business systems, while also ensuring data integrity. Seek candidates whose IT/IS knowledge is complemented by a strong understanding of computer system validation and IQ, OQ, PQ protocols.
Company will pay excellent wage to attract and retain this candidate.
Key Things to Note:
- It is a Direct Hire opportunity and an immediate need.
- The company operates a laboratory and a manufacturing operation in the RTP site. Familiarity with IT/IS-related GxP regulations as well as 21 CFR Part 11 will be essential.
- This BSA will be responsible for lab and manufacturing systems such as electronic lab notebooks, LIMS, chromatography systems, scientific data management systems, etc. Familiarity with these and similar systems will be important.
- This BSA will also be responsible for Quality Assurance related to these systems, including audit prep. Right candidate will bring substantial experience with computer system validation and Quality Assurance functions.
- The company is in building mode and is aggressively enhancing and/or replacing Business Systems. Seek candidate who complements his/her IT/IS knowledge and skill with a very strong work ethic, desire to contribute and a keenly focused, mission-driven work style.
- Growth potential is enormous.
This Business Systems Analyst will be responsible for the implementation, administration, support, and maintenance of computerized lab and manufacturing systems, including ensuring Validation, Data Integrity and 21 CFR Part 11 Compliance for the site’s GLP and GMP regulated systems.
- Participates in the design, implementation, and maintenance of the business systems roadmap for the GMP, GLP, and non-GxP lab systems, and implement process improvement initiatives.
- Provide strategic and technical expertise related to electronic data integrity, 21 CFR Part 11 Compliance, and computerized system validation.
- Ensure all required installation, administration, support and maintenance performed by IT administrators, engineers, and external vendors are properly executed, tested, and documented to maintain compliance.
- Work in collaboration with our Quality Assurance department to create, update, review, and approve SOPs, validation documents, change control documents, etc. and conduct periodic audits, system reviews, and tests related to our IT systems and processes.
- Collaborate with scientists, QA, vendors, and IT colleagues throughout the system life cycle of our manufacturing and lab systems including systems procurement, validation, operation, management, and decommissioning.
- Serve as the primary point of contact for all IT-related questions and requests during GxP audits and quality investigations.
- Manage service contracts, vendors, and consultants providing installation and maintenance service for relevant IT systems.
Targeted candidate will offer a related degree and 5+ years in an IT/IS role supporting systems and processes in a GMP, GCP, and/or GLP regulated environment. Experience as a Business Systems Analyst (or very similar user-driven role) will be important.
Other priorities include:
- Substantial experience with lab and/or manufacturing systems such as electronic notebooks, lab or manufacturing execution systems, LIMS, chromatography systems, scientific data management systems, etc. and the servers and networks that support them.
- Demonstrated expert knowledge of 21 CFR Part 11 and/or EU Annex 11, GAMP 5, data integrity, Computer System Validation and IQ, OQ, PQ protocols
- Experience with the validation of virtual server environments particularly VMWare, Windows Servers, SQL Servers, Remote Desktop Servers, and AppAssure Backup software is preferred
- Specific experience with use or validation of lab systems such as Empower 3, DESIGO, PEMAC, FTIR, and OMNIC and manufacturing automation systems preferred.
- Strong analytical, diagnostic, and technical resolution skills
In addition, we seek a quick study and a go-getter. This is a tremendous opportunity but requires a highly capable and smart overachiever who thrives when challenged.
Please forward Word resume for prompt consideration. NC candidates targeted.