🚀 go-pugleaf

Technical Lead in the concept development, design, implementation, and
launch of a full scale Analyst Software Validation Package for use in our
customer's cGxP, GxP environments.



RESPONSIBILITIES:



�         Define, maintain and implement technical development plans and
work schedules that reflect the project's goals and objectives, with input
from Product Development and Applied Biosystems Joint Venture (JV) partner
Marketing/PAL managers.

�         Conduct requirements analysis on the content and delivery
mechanism for a full-scale validation package for the Analyst Software and
prepare functional requirements document.

�         Lead the development of documentation as required for this
package, including a validation strategy, validation protocols and
summaries.

�         Apply the appropriate regulations, guidance documents, and
industry standards pertaining to use, validation and maintenance of computer
systems, automated process and electronic records.

�         Work with SWD, PTE, TWR and PAL activity centers to coordinate and
collect the applicable validation information and data for the validation
package.

�         Extract and translate from existing user requirements for systems
into testable functional and system specifications for software and
hardware.

�         Extract and if necessary translate from existing SWD and PTE
documentation, the tests necessary to validate the requirements.

�         Where necessary develop user requirements, IQ/OQ protocols and
acceptance criteria.

�         Organize the delivery of beta packages to beta customers and
obtain feedback on the validation package.

�         Conduct tests to demonstrate compliance of the end product with
stated requirements.

�         Deliver the final Validation Package.

�         Organize the support of pertinent validation activities in the JV
support centers.



QUALIFICATIONS:



�         Bachelor's or Master's degree in Pharma Sciences, related science
field or Computer Science.

�         Thorough working knowledge of GxP (GMP, GLP, GCP). Experience
working in an FDA or EPA regulated environment.

�         Thorough understanding of CFR 21 Part 11 is required.

�         Familiarity with related software validation guides and
regulations is preferred.

�         Familiarity with ISO standards is preferred.

�         At least 10 years of direct experience with validation of computer
systems and laboratory instrumentation in the pharmaceutical, chemical or
related industries

�         Previous experience in writing validation protocols for LC/MS and
LC/MS/MS laboratory instruments and their corresponding computer systems is
required.

�         Previous experience in generation of complete software validation
packages is required.

�         Previous experience where FDA auditors have inspected validation
work is required.

�         Previous experience with use of AB/MDS SCIEX instruments is
preferred.

�         Experience with MS Office, scripting applications, VB and Adobe
Software packages is preferred.



Qualified candidates should submit their resume to greg@huntech.com