Senior Technical Operations Officer

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.

Job Description

Key Roles/Responsibilities:

• All aspects involved in the introduction of repeat processes into Manufacturing, including;
  • Establishing the scope of change for an incoming process through effective communication with the project team / client;
  • Work within the Piramal QMS to initiate, manage and complete requests for change;
  • Prepare and update documentation to be used in the GMP manufacture of commercial and repeat clinical products;
  • Drive the review process of updated documentation through to approval;
  • Perform risk assessments for the use of manufacturing equipment and unit operations as required;
  • Review OI, OP and SOPs as required to ensure they are accurate with current practice;
  • Prepare manufacturing schedules;
  • Provide pre-campaign training for manufacturing staff;
  • Assist in deviation investigations associated with GMP manufacturing campaigns of re-sited projects;
  • Prepare end of campaign reports for all re-sited projects, detailing campaign performance and lessons learned.
• 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

Problem Solving - The ability to accurately assess a situation and derive a positive outcome.

Decision Making - The ability to quickly assess information to arrive at the best possible choice and being able to provide reasoning that support your decision.

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:-

• Minimum 12 months of ADC manufacturing 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.
• Experience of performing investigations, root cause analysis and CAPA close out.
• Excellent verbal and written communication skills