KH
Quality Control Technical Consultant
Katalyst Healthcares & Life Sciences
🇲🇦 Morocco
On-site
4 months ago
- GMP
- triage
- GxP
- PLC
- DCS
- ITIL
- ServiceNow
- Change Management
- Configuration Management
- CAPA
- Veeva
- MS Office
- Visio
- MS Project
- Citrix
- Windows
- Windows Server
- SQL
- LDAP
- Group Policy
- TCP/IP
- Lean
4 months ago
We are looking for a candidate who can support QCIT operations in a GMP environment, including:
- Developing and executing periodic validation activities (backup and restore testing, user access reviews, and audit trail reviews)
- Front-line client support and triage (initial assessment and coordination of repair activities when systems are down)
- Supporting GxP workstation patching activities
- Supporting decommissioning activities (for example, final backups and account deactivations)
- The QC IT Application Analyst collaborates with the business and IT teams to provide
- project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development.
- The QC IT Application Analyst manages their work with limited oversight-
- The scope of work includes, but is not limited to the following:
- Project upgrades from win 7- win 10
- Provide oversight of vendor-provided solutions
- Handle ad-hoc technical requests from both internal and external partners in accordance with projects that are assigned.
- Work with other Direct team members for decisions, and clarifications as needed
- Must be able to juggle multiple projects and deliverables, and split billing time
- between projects where needed.
- Experience with performing design testing of application to help author SDLC
- documents, including SDCS, URS, FRA, Admin Sop, IQ, IOQ, ATR, Application Flow diagrams, etc.
- Must poses GXP experience with lab equipment.
- IT Technology Skills & Competencies
- IT Experience deploying and supporting Quality and Manufacturing Systems including Analytical Instruments – Empower, Chromeleon, SOLO VPE, Client Unicorn, Nova Biomedical Bioprofile CDV and Flex2, Roche Cedex, Roche
- LightCycler 480, FileMaker Pro, Bartender, Charles River EndoScan-V, Client DataPro2, Informait InForm/CC, Lonza WinKQCL, Mettler Toledo LabX,
- PerkinElmer Asset Genius, Thermo WebAdmin for TruScan RM Analyzer, and various Laboratory desktop applications used in GxP environment.
- Familiarity with Automation systems such as SCADAs, PLCs, DCS, Client, Historians
- Experience with Computerized Systems Validation (CSV), 21 CFR Part 11 egulations, and Data Integrity compliance
- Experience working with ITIL processes in ServiceNow such as Incident
- Management, Change Management, Problem Management, Asset and Configuration Management (CMDB)
- Familiarity with following tools and processes TrackWise – CAPA, Deviation, Change Control Veeva – Document Workflows
- Familiarity with Operational Excellence and/or Continuous Improvement processes
- Knowledge and familiarity of following Tools and technologies MS Office 365, MS Visio, MS Project Citrix, Windows Desktop, Windows Server, SQL Databases, LDAP, Group Policy, TCP/IP Networks, Server Virtualization, RDP, Backup and Restore Architectures – 2 Tier, 3 Tier, On-premise, Cloud
- Must be able to lift, push, pull and carry up to 30 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning.
- Will potentially be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails, or any oral food, tabaco, candy etc. may be used in the QC / Manufacturing environment.
- During onboarding and training Onsite requirement will be 5 days per week.
- Afterwards minimum 3-4 days a week onsite is required.
- Must be able to work overtime as required.
- May be required to work in a confined area
- More than 5 years relevant IT/business experience, analysis, and documentation
- of business and technical requirements (required)
- Experience with software application implementations in GxP environment
- (required)
- Bachelor's degree or equivalent in information technology, computer science, engineering, or business administration,
- Experience in the Pharmaceuticals or Life Sciences industry (preferred)
- Experience consulting or working in a complex, global matrix organization
- (preferred)
- Knowledge of Lean operational techniques (preferred)
Quality Control Technical Consultant · Katalyst Healthcares & Life Sciences