Quality & Compliance Support Engineer - IT Infrastructure Services (8-10 yrs)

Job Title : Quality and compliance Support

Job Type : Remote

Job Experience: 8+Years

Job Description :

Key Responsibilities :

- Support IT Infrastructure qualification activities e., creation and maintenance of the qualification documentation

- Ensuring that IT services are following relevant internal and external requirements.

- Work in the agile framework as part of a product team and work towards the team's goals, based on Product Owner and Business Owner's requirements.

Main job tasks :

- Defining and executing qualification strategy for IT Infrastructure both in the project and operations phase

- Perform qualification activities including Implementation plan, Implementation report, Design Review, Test strategy and execution etc.

- Performing assessments such as Supplier assessment, IT risk assessment, functional and data integrity assessments etc.

- Work with improvements of the qualification process and the vendor cooperation

- Support SOP updates related to qualification.

- Guide product teams on deviations.

- Support Service Manager and Product Owner in creation and maintenance of service documentation and instructions

- Help product teams with audits and inspections including closing any identified finding.

- Train product teams on quality and compliance e. IT Infrastructure.

- Quality and compliance support on IT Infrastructure Services.

- Employees are expected to act independently to ensure tasks are performed as agreed with product owner or other team members.

- Manage internal & external stakeholders

- Communicate and collaborate with Product Teams and IT Infrastructure vendors.

Knowledge, skills and experience :

Experience :

- 8+ years of experience working within IT.

- 8+ years of experience with Infrastructure qualification, compliance requirements in pharmaceutical industry.

- Good understanding of GAMP 5 Guide (GAMP 5) and various Regulatory requirements including CFR part 11, EU Annex 11.

- ITIL processes especially Change, Release and Configuration management.

- Experience with working with Agile framework.

Personal skills :

- Excellence interpersonal, communication and presentation skills

- Ability to represent relations with internal and external stakeholders including Suppliers and Authorities

- Self-managed, strong personal drive with coaching skills to motivate employees, colleagues and peers towards delivering excellent performance and results including continuous improvement.

- Ability to analyse and solve complex issues in a timely and structured manner.

- Ability to collaborate and communicate with stakeholders, both internal and external at all levels.

- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones