Quality Assurance Specialist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dublin
• State/Province Dublin
• Country Ireland

Job Description About PSC Biotech Who are we?

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

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Requirements Responsibilities

• Provide direct Quality support to production and supportareas.
• Provides presence on the shop floor to support complianceand data integrity.
• Review and approve GMP documentation/data for accuracyand completeness.
• Review and approve executed production documentation suchas electronic batch records and logbooks to ensure accuracy and compliance withcGMPs and company procedures and ensures completion of proper remediation oferrors.
• QA support, review and approval of Commissioning andQualification lifecycle documents for capital projects and new equipment.
• QA support, review, and approval for Performancequalification (PQ) & Process Validation activities across site.
• Support sustaining and QC activities such as changemanagement, deviations, CAPAs, equipment requalification, periodic review, sitemaintenance and Calibration Programs.
• Provides support to internal audits and regulatoryinspections.
• Collaborates with cross-functional team members in theidentification and implementation of continuous improvement initiatives andaction plans.

Technical

• Understanding of cGMPs and of regulatory requirements asthey apply to the pharmaceutical field or a related area.

Qualifications

• Leadership skills coupled with good oral and writtencommunication skills.
• Demonstrated interpersonal skills including flexibility,collaboration and inclusion skills and ability to work/ upskill/coach a teamenvironment.
• Demonstrated analytical aptitude, critical thinkingskills and problem-solving skills.
• Bachelor's degree, in a scientific or engineering field.
• 3 years of relevant post-degree experience in a GMPenvironment: manufacturing,laboratory, quality, operations, technical, orregulatory function.