Senior QA Associate

The Quality Assurance (QA) Snr Associate will typically report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve as Quality point of contact for Packaging operations, as well as support the complaints function.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.

Key Responsibilities:

* Perform all activities in compliance with safety standards and SOPs
* Observe and provide real-time Quality oversight and support for Packaging unit operations.
* Perform purposeful presence Quality walks on the shop floor to ensure permanent inspection readiness.
* Participates in Customer complaint investigations.
* Perform Packaging Quality audits on every Packed lot.
* Provide Quality support for triage of atypical events
* Quality oversight of minor investigations, including review and approval of Deviations for closure ensuring compliance with appropriate documentation
* Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
* Provides training and advice to staff in order for them to perform their desired functions.
* Write, review and approve Standard Operating Procedures in accordance with Policies.
* 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 (4 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
* Fluency in SAP, Trackwise, Excel, Teams, etc
* Strong organisational skills, including ability to follow assignments through to completion
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
* Experience working with combination products or devices in packaging-related or complaint-handling activities
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
* Operational Excellence experience