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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, ensuring 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 supports 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 principles. Experience of performing investigations, root cause analysis, and CAPA close out. Excellent verbal and written communication skills.
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- 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 supports 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 principles. Experience of performing investigations, root cause analysis, and CAPA close out. Excellent verbal and written communication skills.
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