Quality Assurance Specialist
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Job Description
About PSC Biotech
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.
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.
Role Functions
Responsible for supporting equipment qualification/ requalification through review and approval of pre and post execution protocols.
Responsible for supporting deviation close out for assigned areas and initiating/following up on corrective and preventative actions.
Drive compliance with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Partner with colleague s cross-functionally to provide support and advice on a day-to-day basis and on a project basis, including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries, etc.; thereby ensuring department is audit/inspection ready.
Actively participate in Plant/Quality committees and work with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
Support the development and implementation of improved quality reporting measures for area of ownership. Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete, review on a continuous basis.
Ability to make rapid and informed Quality decisions.
Be an advocate of continuous improvement in the Quality Management Systems.
Conduct self-inspections and support external audits as appropriate.
Requirements
5 8 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment
Equipment and process validation
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Experience of Sterile filling processes and equipment and associated GxP requirements
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Proven decision-making capability with accountability and responsibility
Report, standards, policy writing skills required
5 8 years experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment Equipment and process validation Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Experience of Sterile filling processes and equipment and associated GxP requirements Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance Proven decision-making capability with accountability and responsibility Report, standards, policy writing skills required Proficiency in Microsoft Office and job-related computer applications required Bachelor Degree or higher preferred: ideally in a related Science discipline #LI -FP1
Employment Type
Full Time
