Key Roles/Responsibilities:
* All aspects involved in the introduction of repeat processes into Manufacturing, including:
o Establishing the scope of change for an incoming process through effective communication with the project team/client;
o Working within the Piramal QMS to initiate, manage, and complete requests for change;
o Preparing and updating documentation to be used in the GMP manufacture of commercial and repeat clinical products;
o Driving the review process of updated documentation through to approval;
o Performing risk assessments for the use of manufacturing equipment and unit operations as required;
o Reviewing OI, OP, and SOPs as required to ensure they are accurate with current practice;
o Preparing manufacturing schedules;
o Providing pre-campaign training for manufacturing staff;
o Assisting in deviation investigations associated with GMP manufacturing campaigns of re-sited projects;
o 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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