Quality Assurance Specialist- Shift

- Industry Pharma/Biotech/Clinical Research
- Work Experience 1-3 years
- City Carlow
- State/Province Carlow
- Country Ireland

Job Description

About PSC Biotech

Who are we?

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 points 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 to 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 through Learning & Development, in-house training, mentorship, and 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 met.

Overview

The Quality Assurance Specialist within Our Company is required to:

- Technical knowledge of sterile manufacturing processes
- Perform timely reviews of batch documentation, investigations, and reports; highlight and assist in the resolution of concerns commensurate with the risk
- Respond quickly to unplanned events and technical issues
- Operational experience of quality systems in a dynamic manufacturing environment (eg SAP, Trackwise, MES)
- Full understanding of relevant quality and compliance regulations; knowledge of cGMP and US/EU regulatory requirements
- Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
- Support the spot check/walk-through process of the production lines
- Involved in customer complaint investigations if required

Requirements

Responsibilities

- Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
- Understanding of sterile manufacturing operations is preferred.
- Ability to learn and utilize computerized systems for daily performance of tasks.
- Ability to prioritize, manage multiple tasks, and meet deadlines.
- Perform timely reviews on batch documentation (EBRs)/line clearances; assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards
- Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

Qualifications & Experience - Knowledge & Skills Requirements

Skills and Knowledge:

- Bachelor’s Degree or higher preferred in a Science discipline

Typical Minimum Experience:

- 1-2 years experience in a Quality Role at pharmaceutical manufacturing facility, preferably aseptic manufacturing

Technical:

- Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Knowledge of cGMP and GDP; essential report, standards, policy writing skills
- Competent in the use of MES and SAP

Shift Pattern:

- This is a shift position – 4 cycle 12 hours per shift
- Week 2: short week - Wed and Thurs Days
- Week 3: long week - Monday–Tuesday nights, Friday, Sat and Sun Days

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