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Job Description
Key Roles/Responsibilities:
1. 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.
1. 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:
1. Teamwork - As a team member, the ability and desire to work cooperatively with others on a team.
2. Communication - The ability to ensure that information is passed on to others who should be kept informed.
3. Building Collaborative Relationships - The ability to strengthen partnerships with others inside the organization who can provide information, assistance, and support.
4. Attention to Detail - Ensuring that one's own and others' work and information are complete and accurate.
5. Problem Solving - The ability to accurately assess a situation and derive a positive outcome.
6. 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.
7. Interpersonal Awareness - The ability to notice, interpret, and anticipate others' concerns and feelings, and to communicate this awareness empathetically to others.
8. 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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