Senior QA Associate

1 month ago

Dublin, Ireland PSC Biotech Ltd Full time

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Senior QA Associate

 

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 Snr QA 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, 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.



Requirements

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:

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

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

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

·        Review and approval of deviations for closure ensuring compliance with appropriate documentation.

·        Participates in customer complaint investigations.

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

·        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 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 (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.

·        Strong organizational 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 in aseptic operations, protein formulation, vial and syringe filling.

·        Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.



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