GxP Validation Manager

Zifo•Bloomington, IN

1d•Onsite

About The Position

Zifo is looking for a GxP Validation Manager to join their team in Bloomington, Indiana. This role requires full-time presence (5 days / week) at the client site in Bloomington, IN and is not eligible for relocation assistance. The manager will be responsible for leading the GxP Validation, Data Integrity and Remediation efforts for Analytical Instruments and Computerized Systems in accordance with applicable policies, procedures, and regulatory requirements. Zifo is a global R&D solutions provider focused on industries such as Pharma, Biotech, Manufacturing QC, Medical Devices, and specialty chemicals. They serve customers globally, including 18 of the Top 20 Biopharma companies. Zifo fosters a curiosity-driven, science-focused, and employee-built culture characterized by a passion to learn and a spirit of teamwork.

Requirements

Bachelor or Master’s degree in Lifesciences or Computer Sciences
7+ years’ experience with Computer Systems Validation is required for this role
Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirements
Experience with laboratory or GxP systems validation like ELN, LIMS, QMS and Instrumentation Systems etc.
Experience with working on long term multiple site engagements and remediation programs.
Experience working with global team (offshore) in delivering validation project deliverables and collaborate with global team towards project success.
Awareness of using electronic document management systems to create and execute qualification protocols

Responsibilities

Define validation Strategy for computerized systems and analytical instruments utilized in GxP QC and Manufacturing labs
Understand SDLC process and SDLC methodology such as agile etc.
Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
Participate/conduct Risk Assessments
Develop and maintain policies and procedures
Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)
Perform Data Integrity Assessments for analytical instruments and Computerized systems and conduct meetings with stakeholders to discuss on the remediations of observations from review.
Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
Participate in user review meetings, discussions with Quality Assurance and Compliance groups
Must have experience working with global team (offshore) in delivering validation project deliverables and collaborate with global team towards project success.
Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
Act as a liaison between Zifo remote teams and customers
Responsible for Project Risk Management, escalation management, stakeholder communication, status reporting etc.
Author/Review validation life cycle documents for client’s review and approval
Act as a business consultant to support end users of the system
Route drafted documents for review
Route reviewed documents for workflow approval
Request approval workflows for documents
Execute approved qualification protocols in GxP facility along with SMEs.
Must be aware of using electronic document management systems to create and execute qualification protocols
Understand and manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
Participate in internal initiatives around Compliance and Validation