Applicants are invited for the permanent role of Quality Specialist for commercial and Clinical Product Manufacture.
- Manage, support and Assist in the co-ordination of the QA operational duties related to product disposition (commercial and clinical).
- Participate in deviation investigations and risk assessments related to manufacturing deviations ensuring appropriate root cause analysis is performed and associated corrective/preventive actions are implemented.
- Participate in change management activities related to manufacturing processes (commercial and clinical) ensuring appropriate change assessments are performed and change actions are correctly identified and implemented.
- To review Change Controls/SOPs and related documentation for compliance with Regulatory approvals and GMP and site requirements.
- Deviation review and approval ensuring all possible causes have been documented and either justified as not required or included and discussed, appropriate issue resolution and CAPA monitoring.
- Review and approval of validation/qualification documents.
- Application of revised Pharmaceutical Regulations.
- Ensure adherence to the best health and safety standards.
- Proficient in the use of the Quality Systems in operation in the Organisation.
- Review and implementation of continuous improvement projects to ensure the efficient and compliant operation of these systems that will reflect current regulatory thinking and will withstand scrutiny during regulatory or customer audits.
- Proven experience within the Pharmaceutical Industry in a QA/QC/Compliance role.
- Qualified Pharmacist or Graduate Diploma in Pharmaceutical Manufacturing Technology or equivalent “Qualified Person” status as defined by EC Directive 2001/83/EC is beneficial but not a requirement.
Alkermes provides equal employment opportunities to all employees and applicants for employment