Quality Assurance Engineer - Validation

Job Description

Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer 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.

·        To Implement and maintain global and local 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 and 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

Qualifications

·        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, ISO and other regulations and experience in US and international regulatory agency inspections.

·        Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility.

·        Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.

·        Excellent oral and written communication skills with strong technical writing experience required.

·        Experience in internal / external audits, identify findings, drive resolution and provide closure report.

·        Proficient skills in solving complex problems and ability to bring issues to resolution.

·        Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.

·        Must be able to successfully pass a pre-employment drug test and background check.

Experience working globally with diverse teams and cultures

Additional Information

All your information will be kept confidential according to EEO guidelines.