The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will sit in the PQA organisation responsible for packaging activities and their main responsibility will be complaint investigations.
The scope of the complaint investigations will extend to formulation, aseptic filling and inspection and as such the Snr Associate will gain exposure to all of these processes.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
- Perform complaint investigation related to product manufactured at ADL including Formulation, Filling, Inspection and Packaging.
- Perform all activities in compliance with Amgen safety standards and SOPs
- Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
- Provide Quality support for triage and investigation of Deviations
- Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
- Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
- Review and approve cGMP records (e.g., deviations, CAPA, protocols, reports & SOP) ensuring compliance with appropriate documentation
- Support continuous improvement and Operational Excellence initiatives
- Any other tasks/projects assigned as per manager's request.
Basic Qualifications & Experience:
- University degree. Engineering or Science related discipline preferred.
- Relevant experience (2 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role
Preferred Qualifications & Experience:
- Excellent written and verbal communication skills
- Experience working with dynamic cross-functional teams and proven abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigation
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
- Operational Excellence experience
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.