The holder of this position is charged with leading effort to prove control of the critical aspects of Alkermes operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.
- Subject matter expert in at least two main area of validation ( Process/Cleaning/Equipment /Utilities /Facilities/Computer Systems)
- Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding
- Determine levels of importance or risk to be assigned to elements under review – using scientific rationale to justify scale of effort.
- Demand / extract appropriate definition of science underpinning element (product, process, equipment, cleaning regime) under review
- Link all efforts to the patient
- Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed equipment, process, equipment, facility or procedure
- Understand the science and areas of technical knowledge that underpin area of focus & must be able to apply this knowledge in the development of validation approach and in the presentation, documentation & review of outcome
- (As required) Move to others areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
- Represent the validation group (i.e. in certain forums position holder will be the sole representative of the Validation department, in such circumstances the validation scientist should be prepared to answer for the whole group and/or where unable to do so immediately should take ownership for timely follow-up actions)
- Contribute to validation policies, guidance documents (SOPs, VMPs, VPPs) detailing best practice approach
- Understand best industry practice, current developments and opportunities arising for Alkermes
- Present to potential clients on why validation approach in Alkermes provides both assurance of a safe pair of hands (compliance and adequacy of transferred process) and is effective (time & cost)
- Actively participate in Professional/Industry groups ~ to learn, to influence and to represent Alkermes
- Much of the validation Department activity is concerned with maintenance of GMP compliance through monitoring, review, assessment and qualification of activities. The holder of the position will be required to contribute effectively in these areas. Contribution in areas such as change control, PPI’s, APR’s, and PR’s, VMP’s and SOP updates will be required as well as attendance in forums such as PRB and KPI reviews (see above with regard to representation)
Ensure Validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands and that they do so effectively. The holder of this position is also responsible for the maintenance of these validation systems and ensuring compliance of Validation corrective actions.
- Experience using Val-genesis Software a plus
- Must be computer literate.
- Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment.
- Must be (or quickly become) familiar with the relevant areas of science (some indicated in table below) applicable in area(s) of deployment.
- Must be (or quickly become) familiar with the general areas of Technical knowledge / understanding indicated in table below.