1. Performs GxP Activities and ER/ES Assessment, Computerized Systems Risk Assessment and Change control process for computerized systems.
2. Very strong contender of CSVC
3. Have excellent knowledge of predicate rules and their applicability
4. Maintain effective inter personal relationship with Stakeholders
5. Providing support to business user in the identification and implementation of SOPs.
6. Hands on experience in Design and implement Site IT Compliance and risk management projects / programs
7. Should be Hands on with Regulations and Compliance for corporate and Site level system requirements and adherence
8. Should practices Life Sciences IT Compliance (FDA (21 CFR Part 11), IMDA, PICS, EUDRALEX) on day to day operations
9. Support audits during internal or external audits.
10. Should have very good understanding of SAP and related applications.
11. Should have very understanding in Gap Assessments, Stand Alone Systems and Spreadsheet Validation
For the Automation position
1. Manage automation test suite development across all major enterprise applications and work with multiple stakeholders
2. Should have hands on experience using Automated testing tools.
3. Coordinate and conduct Performance Test activities (Load, Stress, Logic, etc)
4. Manage the script approval framework for all automated scripts with a specific emphasis on scripts to be executed against validated applications
5. Coordinate the regression test activities for any patch deployment across Enterprise applications, including HRSP every 6 months.
6. Ensures work is performed in compliance with regulations
7. Investigate, diagnose and resolve incidents with customers.
8. Support audits during internal or external audits.
9. Ensure that Policies/SODs related to test automation are updated and enforced.
10. Serve in a technical role providing guidance to other team members and other employees within information services.
11. Resolve directly issues with internal customers, contractors and other internal stakeholders.
12. Should have very good experience in SAP and their modules.