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Position profile:
The Validation Specialist role is a Fixed Term Contract (FTC) position to support a new API product introduction project on the site at Grange Castle. The successful candidate must be capable of working both on their own initiative and as part of a very flexible team in a demanding, regulated environment. They are required to proactively contribute to the delivery of targets within quality, safety and environmental requirements and on schedule.
Key tasks and Responsibilities
Technology Transfer
Play a leadership role in the introduction of a new process together with the preparation and execution of process validation programs.
Be the Subject Matter Expert in validation aspects of the process including assessment of critical parameters, implementation of control strategies and definition of cleaning program.
Support cleaning and process risk assessment programs to define validation and cleaning approach.
Preparation and execution of plans, protocols and reports associated with process validation and cleaning validation ensuring compliance with current industry regulations.
Quality Systems and GMP
Perform operations in accordance with TILGC quality standards, current Good Manufacturing Practices (cGMP) and all other relevant policies, procedures, regulations and standards including Health & Safety and Environmental (HSE) Legislation.
Complete required documentation in an accurate and timely manner. Such documentation would include (but not be limited to) records required by SOPs, Logbooks and Labels as well as HSE records.
Generate documentation associated with their activities as required by cGMP and review Standard Operating Procedures (SOPs), Batch Manufacturing Instruction and Record (BMRs), Logbooks, Labels, In-Process Test documentation, and other regulatory documentation (Quality, Health & Safety, Environmental) as required.
Safety & Environment
Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Adhere fully to all safety policies, procedures and regulations.
Notify the relevant Manager (or other appropriate responsible person) in a timely and comprehensive manner of any breach of HSE policy, procedure or regulation.
Training
Actively participate in all training and assessment activities (internal and external) in relation to themselves, manufacturing personnel or other employees.
Ensure timely completion of all SOP training and assessment tasks.
Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
EDUCATIONAL REQUIREMENTS:
Primary degree in a scientific discipline
RELEVANT EXPERIENCE:
Experience of supporting an API Technology Transfer.
3-5 years experience of working in a validation role in a regulated environment.
Excellent knowledge of validation regulations and guidelines.
A strong technical understanding of processes and equipment.
SKILLS AND COMPETENCIES:
Excellent verbal and written communication skills
Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
Grange Castle, Ireland
Employee
Fixed Term (Fixed Term)
Full time
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