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;
Working within the Piramal QMS to initiate, manage, and complete requests for change;
Preparing and updating documentation to be used in the GMP manufacture of commercial and repeat clinical products;
Driving the review process of updated documentation through to approval;
Performing risk assessments for the use of manufacturing equipment and unit operations as required;
Reviewing OI, OP, and SOPs as required to ensure they are accurate with current practice;
Preparing manufacturing schedules;
Providing pre-campaign training for manufacturing staff;
Assisting in deviation investigations associated with GMP manufacturing campaigns of re-sited projects;
Preparing 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 are 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 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.
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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 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.
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