Computer Systems Quality Engineer, Quality Assurance
We have an immediate opening for a Computer Systems QA Engineer at our Deerfield Beach, Florida headquarters.
Our company provides final assembly, labeling and packaging services of drug delivery devices to the pharmaceutical and biotechnology industries and soon clinical fill finish capabilities. Scientist and Engineers work closely with our partners to continuously create and introduce innovative, patient centric, solutions to enhance patient compliance and user experiences. Dedicated project managers work closely with their counterparts at the partner company to develop and maintain program timelines in line with the strategic and business needs of our partners. In addition, for those partners who wish to have SHL handle the final assembly process, SHL Pharma offers robust final assembly and labeling capabilities that enable our partners to improve speed to market and reduce the number of parties involved as well as have one clear point of responsibility.
Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight for global GxP systems, applications and infrastructure associated with GxP Systems. The Engineer will contribute improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of Operations, Process Development and IT. The engineer will approve validation, change control, investigation of events as well as provide Quality oversight and/or Quality approvals for GxP systems. The CSQA Engineer will provide oversight of SHL Pharma GxP related applications, and established Quality Operating procedures. In addition; will maintain a list of all computerized systems that are used in support of manufacturing operations, assure 21 CFR Part 11 pre- and post-assessments are performed on all systems and that computerized systems are released to production in accordance with local and global policies and procedures.
The CSQA Engineer will review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies. In addition; will provide guidance to project teams on the deliverables required as part of the validation package. Assure that computerized systems are in the requalification program and are part of the program for security access roster review. Assure that all computerized systems are compliant with regulatory guidance’s, including 21 CFR Part 11 and Data Integrity.
- To Implement and maintain global procedures for computerized systems validation
- To drive standardization and continuous improvement activities across the global and local quality network
- To provide QA oversight, review and approval of the activities related to the design, test, implementation and maintenance of supported GxP systems.
- To help plan audit program and execute audits of:
- Suppliers of computerized systems, components and services
- Computerized systems, projects and processes related to Computerized system
- Computerized systems at SHL’s partners (e.g. CMO Customers}, upon request
- To monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure.
- To identify an communicate risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk.
- To ensure deviations from established procedures are documented per procedures
- To ensure that all changes that potentially impact product quality are documented per procedure.
- To ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
- Advises site management regarding Quality Assurance issues.
- Bachelor’s degree in Computer Science / Computer or Biomedical Engineering
- Minimum 5 years’ experience in a Quality Assurance role related to
- computerized systems compliance
- Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems
- Must have a strong knowledge and application of the CFR’s and cGMP’s
- Comprehensive knowledge of FDA, EMA, JP and other regulations and
- experience in US and international regulatory agency inspections.
If you possess the required experience and qualifications and want the challenge of growing with our company then submit your resume in confidence to our Human Resources Department at RecruitUS@shl-group.com.Apply for this job