QA Senior Associate

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Overview:The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be 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.This is a 24/7 shift role required to support manufacturing operations. Weekend work may also be required.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.

* Experience working in aseptic operations, protein formulation, vial and syringe filling.

* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.Key Responsibilities:

o Perform all activities in compliance with safety standards and SOPs.

o Write, review and approve Standard Operating Procedures in accordance with Policies.

o Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.

o Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.

o Participates in customer complaint investigations.

o Provides training and advice to staff in order for them to perform their desired functions.

o 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.

o Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

o Review and approve cGMP records ensuring compliance with appropriate documentation.

o Support continuous improvement and Operational Excellence initiatives.

o Any other tasks/projects assigned as per manager's request.Basic Qualifications & Experience:

o University degree. Engineering or Science related discipline preferred.

o 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:

o Excellent written and verbal communication skills.

o Experience working with dynamic cross-functional teams and proven abilities in decision making.

o Strong organizational skills, including ability to follow assignments through to completion.

o Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.

o Experience working in aseptic operations, protein formulation, vial and syringe filling.

o Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales