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Senior QA Associate I

  • Alkermes
  • Roscommon

To apply for this job please visit www.linkedin.com.

About the job

Description

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:

Key Responsibilities

    • 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.

Requirements

  • 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.

To apply for this job please visit www.linkedin.com.