Applicants are invited for the permanent role of Quality Specialist (Qualified Person) for commercial and Clinical Product Certification. This role may report to the Director, Quality Assurance.
- Certify medicinal product in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16 and Annex 13 where applicable for Investigational Medicinal Products, and in accordance with appropriate US and other territory regulations.
- Assist in the co-ordination of the QA operational duties related to product disposition.
- Participate in/Lead investigations and risk assessments related to deviations/complaints and changes and ensuring appropriate actions are implemented timely.
- To review Change Controls/SOPs and related documentation for compliance with Regulatory approvals and GMP and site requirements.
- Ensure product release procedures comply with current regulatory and company requirements.
- Manage Interaction with clients.
- 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.
- 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.
Alkermes provides equal employment opportunities to all employees and applicants for employment