Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years.
In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
The Computerized Systems Validation and Quality Assurance Contractor
will be responsible for supporting the Computerized System project team in the generation, review and approval of system validation and infrastructure qualification documentation, and execution of protocols where applicable, in accordance with FDA regulations/guidelines,
GAMP and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities to ensure compliance with regulatory requirements.
The scope includes, but is not limited to problem analysis and investigation for determination of root cause(s), and to take effective corrective action; and working with multi-functional teams on problem resolution and process improvement projects. In addition,
this position will contribute to the development and implementation of validation/qualification tools to improve process monitoring and optimization, and for identifying means of reducing the number of recurring problems. This person will be expected to maintain
and, where applicable, improve the effectiveness of the validation program.
Duties include, but are not limited to, developing, reviewing, providing oversight and approval of validation/qualification-related documents, conducting/leading risk assessments to determine which elements should be validated, and conducting impact assessments
of proposed changes to computerized systems. Main responsibilities are as follows:
- Develop and/or review/approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, User Acceptance
Tests (UAT), Design Qualification (DQ), IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
- Provide QA oversight of all GxP computerized system validation activities: conduct/lead GxP assessments, risk assessments, part 11 assessments.
- Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
- Coordinate validation/qualification activities, propose and implement validation/qualification strategies and serve as the subject matter expert.
- Present project status reports to management as well as project teams.
- Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
- Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
- Lead/participate in supplier site Validation Assessments/Audits and work with suppliers to troubleshoot and improve systems and processes. Generate System Assessment/Audit Reports and follow-up with suppliers on implementation and closure of observations/recommendations
identified in the report.
- Generate or review/update computer system related policies, procedures, templates, forms, etc., as needed to improve/evolve the validation program and implement them.
- Work with Management on system validation planning (both short term and long term) supporting diagnosis of validation problems (both internal and external), implementing corrective and preventive actions to resolve those problems, and support continuous
improvement of validation programs.
- Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP s regulations, GAMP, industry standards, policies and procedures.
- Involve in review and revision of Standard Operating Procedures (SOP).
- Performs other quality and computerized system related duties as necessary.
- Bachelor s Degree in a Scientific or Engineering discipline with a minimum of eight (8) years of computerized system experience with IT compliance/validation/qualification activities.
- Minimum of eight (8) years of experience in an FDA-regulated, GxP-related environment.
- Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.
- Knowledge of industry standards for computer system design, implementation and validation.
- Knowledge of cGxP/QSR, GAMP, ICH, EMA and FDA guidelines.
- Experience with application system validation and infrastructure qualification.
- Experience with vendor audit for computer systems (IT infrastructure, validation etc.).
- Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint, Access).
- Must be capable of demonstrating results and accomplishments.
- Ability to prioritize and successfully manage complex and competing projects within timeline.
- Excellent oral and written communication skills.
- May be required to travel 15% domestically to audit computerized system vendors.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html
-- and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.