Key Roles/Responsibilities:
1. Review of executed PI Sheets for completion accuracy;
2. Work with QA to review and close out any clarifications or queries raised by the client or internally;
3. Work with the Senior Technical Operations Officers to complete actions raised as a result of change control;
4. Work with the document control team to ensure that PI sheets are requested in a timely manner, prior to Manufacturing start date;
5. Work with the Shift team leaders to ensure labels required for manufacture are requested/printed as required;
6. Review and update cleaning and buffer PI sheets;
7. Aid investigations resulting from process related deviations;
8. Collation of data required for end of campaign reports;
9. Review and update SOPs, OIs and PI sheets;
10. Support Senior Technical Operations Officer on project specific tasks as required.
11. Providing hands on support for FAT/SAT, ensure training and documentation to optimize utilization and enhance operational capabilities is created and available for operations.
Competencies:
Teamwork -As a team member, the ability and desire to work cooperatively with others on a team
Communication - The ability to ensure that information is passed on to others who should be kept informed.
Building Collaborative Relationships - The ability to strengthen partnerships with others inside the organization who can provide information, assistance, and support.
Attention to Detail - Ensuring that one’s own and others’ work and information are complete and accurate
Interpersonal Awareness - The ability to notice, interpret, and anticipate others’ concerns and feelings, and to communicate this awareness empathetically to others.
Customer Awareness - The ability to demonstrate concern for satisfying one’s external and/or internal customers.