• Analyzing the technical specifications.

• Evaluation of the application to ensure meets project specifications.

• Developing testing strategies, testcases, etc organizing phased testing.

• Perform testcase executions.

• Monitoring errors in the system raising defects in Jira.

• Collaborating within the team across the the team.

• Creation of UAT data set-up and collaborating with medical affairs team on UAT.

• Follow good documentation practices per the process defined.

• Ensure deliverables are completed per schedule and are of good quality.

• Training the team and taking part in KT/Cross KT sessions.

• Performing review tasks within the team.

Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by

• Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams.

• Developing and utilizing test data sets that support the implementation of test plans and procedures.

• Creating and executing manual test scripts which includes testing software applications for quality and functionality using defined validation protocol and testing techniques.

• Creating associated validation documentation using defined documentation methods.

• Writing comprehensive test plans and reports which set strategy and summarize results.

• Working with application developers in resolving issues and retesting applications.

• Partnering with technical and business teams to achieve understanding of current and future functionality.

• Accurately assessing the risks associated with each design solution / project.

• Exceling at business negotiation, ability to interact with clients, team members, various levels of management and external groups.

• Leading by example with professional and collaborative conduct

• Determining necessary resources for project completion and communicating needs to Group Leader

• Leading testing resources both on site and off shore in daily operational activities for assigned projects

• Compiling and maintaining the documentation for an assigned project and working closely with Quality Assurance to obtain their sign-off and approval

• Communicating status frequently and noting current issues to the Group Leader

• Assisting in the quality review of validation packages and providing related feedback

• Training staff on departmental processes, validation protocol, testing techniques and documentation methods

• Evaluating, monitoring and prioritizing workload of staff to ensure projects are on time; affecting change when necessary

• Offering technical and quality feedback/advice to both internal and external clients

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)

• Assisting in establishing and enforcing departmental standards including defining, documenting and implementing validation standards as needed

• Participating in the modification of company SOPs related to Validation Services

Contributes to team effort by

• Exploring new opportunities to add value to organization and departmental processes

• Working with internal staff including technical staff, project and product managers and applications developers to assist with the review of project specifications

• Helping others to accomplish results

• Performing other duties as assigned and deemed necessary

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

• Bachelors degree in Computer Science, Engineering, Life Sciences or related field required (Extensive experience and training may be considered in lieu of Bachelors degree.)

• 5+ years experience in validation/software testing required.

• Experience working with computer software including Word, Excel and SQL preferred

• 2+ years experience working with clinical trials and/or within pharmaceutical environment required

• Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11 required

• Knowledge of software testing tools required.

• Proven ability in problem solving and troubleshooting.

• Proven mentoring and/or supervisory skills required.

• Ability to work in group setting and independently; ability to adjust to changing priorities

• Excellent attention to detail and orientation toward careful meticulous work

• Strong interpersonal and communication skills, both verbal and written

• Fluent in reading, writing and speaking English

• Strong documentation and organizational skills

• Ability to maintain professional and positive attitude