Technical Operations Officer (FTC)

Key Roles/Responsibilities

JOB DESCRIPTION

• Review of executed PI Sheets for completion accuracy;
• Work with QA to review and close out any clarifications or queries raised by the client or internally;
• Work with the Senior Technical Operations Officers to complete actions raised as a result of change control;
• Work with the document control team to ensure that PI sheets are requested in a timely manner, prior to Manufacturing start date;
• Work with the Shift team leaders to ensure labels required for manufacture are requested/printed as required;
• Review and update cleaning and buffer PI sheets;
• Aid investigations resulting from process related deviations;
• Collation of data required for end of campaign reports;
• Review and update SOPs, OIs and PI sheets;
• Support Senior Technical Operations Officer on project specific tasks as required.
• 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.

Qualifications

Essential Qualifications:-

Degree in a scientific subject or the equivalent GMP experience.

Essential Experience:-

Good chemical/bio-processing industry knowledge

Good working knowledge of GMP

Solid understanding of chemical unit operations and process chemical reaction hazards.

Experience of updating and creating batch record documentation.

Experience of implementing change using change control principals.

Excellent verbal and written communication skills

Experience of working in clean rooms (desirable)