Senior QA Associate
- Experience Level
- Experienced (non-manager)
Ideally to start ASAP
Investigating and complaints
Key candidate must haves:
Excellent written and verbal communication
Experience working cross functional
Demonstrated ability for problem solving
Background, ideally within pharma either manufacturing, Quality, QC
Previous experience with batch review/investigations (min of 2 years experience) or willing to consider graduate at Masters or PhD level
Ideally some complaints handling
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 serve as Quality point of contact for manufacturing operations.
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 all activities in compliance with company safety standards and SOPs
* Write, review and approve Standard Operating Procedures in accordance with company policies.
* Investigate Product Complaints
* 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
* Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
* 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 investigations
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
* Operational Excellence experience