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Senior QA Associate I
- Full Time
- On site
About the job
Applications are invited for a permanent role for a Senior QA Associate I within the Quality Assurance Department reporting to the QA Supervisor. The key responsibilities of the role will cover both manufacturing and development areas and include the following:
- Perform line clearance and GMP monitoring activities for pharmaceutical manufacturing and packaging processes.
- Review, approve and reject raw materials, packaging components and critical consumables for clinical and commercial manufacturing.
- Perform batch record review and approval according to company procedures and ensuring compliance to GMP standards.
- Deviation review, evaluation and closure according to company procedures and ensuring compliance to GMP standards.
- QA rep for root cause analysis activities.
- Perform laboratory record /document review and approval according to company procedures and ensuring compliance to GMP standards.
- Change Control/SOP author and review.
- Perform internal audits with lead auditor.
- KPI data – monitor and evaluate trends, propose CAPAs to eliminate adverse trends.
- Awareness and knowledge of the schedule of manufacture and the material requirements for same.
- Report Writing – monthly reports, trend reports, technical reports.
- Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality and the project or material impacted.
- Interaction with clients/ project collaboration.
- Awareness and application of Pharmaceutical Regulation in own area and department.
- Competent in the use of electronic systems to support own role and department requirements.
- Understanding of data integrity requirements.
- Maintain a high standard of documentation as required in a GMP facility.
- Attend meetings related to key responsibilities.
- Full understanding of GMP requirements in routine operations.
- Third level qualification (Diploma Level 7 FETAC or higher) in Science related discipline with desired 5 years’ experience in a pharmaceutical environment, preferably in a Quality related role is desirable.
- Knowledge and experience of SAP, Sample Manager, Trackwise, Veeva, Ebr and Valgenesis or similar quality systems would be beneficial.
- Good report writing skills and excellent attention to detail is an essential competency for this role.
- Good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Self-motivated with ability to handle changing priorities.
- Proven track record in your current role is essential.
Alkermes provides equal employment opportunities to all employees and applicants for employment.