Senior QA Associate I

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.