About our client
Strides creates a work environment characterized by an open, entrepreneurial culture that fosters creativity and innovation. Within the rigor of an exciting and challenging industry, employees have an opportunity to work with partners in some of the world’s leading pharmaceutical companies, the best talent, and associate themselves with an organization that is recognized for path-breaking initiatives and adherence to the highest standards of ethics and integrity.
As multinational company, Strides is committed to a culture of diversity, reflected in a substantial and varied workforce across the globe. Employment decisions at Strides are based solely on merit, qualifications and abilities, ensuring a strict anti-discrimination policy based on gender, race, colour, nationality, sexual preference, marital status, age, disability, religion or employment status.
Strides recognizes the demands of the current work environment and importance of maintain a balance between personal and professional responsibilities and aspirations. To that end, their HR policies are designed to provide flexibility and help employees lead a more fulfilled life. Flexi time options, state of art gyms, a cricket club, runners club and artists groups are just some of the facilities available to all Stridians. The company also operates a "We Care" programme exclusively developed to address the wellness and health needs of employees through sessions conducted by doctors at Strides facilities.
Strides also has generous Rewards and Recognition Policies like the Leadership Incentive Compensation Plan, the Employee Stock Ownership Plan, the Long Service Award and Cash Award, all ensure that employees across all hierarchies within the company feel valued, motivated, and fulfilled by their work.
- Provide CSV Support for IT and Engineering Projects.
- Ensure that proper Computer Systems Validation procedures are followed during system implementations
- Creation and/or Review Computer Systems Validation documents for various projects.
- Work with vendor provided CSV documents for review and routing for approval
- Work with project managers/SMEs/IT Leads to collaborate on User and functional requirements for systems.
- Routing/Tracking CSV Documents for approval.
- Monitor the status of documents out for approval and inform project managers when their documents are approved
- Oversee Test executions, Review Executed protocols, write up protocol deviations and prepare documentation sets for approvals.
- Provide training for Test Execution methodology to testers prior to test execution.
- Maintain CSV Documentation.
- Manage IT Change Control process
- Perform/Track Periodic Review/Compliance Monitoring of validated systems.
- Bachelors degree in Computer Science, Information Systems or IT related field and/or 3-5 years industry experience
- Experience working in a Pharmaceutical Laboratory environment and a working knowledge of chemistry or chromatography is desired
- Knowledge of GxP Compliance with respect to Computer Systems
- Knowledge of 21CFR Part 11 and GAMP 5
- MS Office suite
Skills & Abilities:
- Good time management skills and the ability to multitask and complete tasks in a timely manner.
- Analytical skills & ability to pick up requirements, workflows and system navigation for IT applications.