Senior Quality Assurance Specialist

About PSC BiotechWho 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 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.

Overview:

Organizes, manages, and controls Project Readiness activities relating to large retrofits and new line introductions. Leads the Project Readiness cross-functional team and manages the development, roll-out, and implementation of all aspects of Project Readiness for large retrofits/new line introductions. Responsible for facilitating and developing cross functional Project Readiness plans, timelines, and resource requirements to ensure successful project delivery including FPO’s

Duties and Responsibilities

• Review Batch Records and material release (including CoA) to ensure compliance with GMP requirements.
• Quality review and approval of Master Batch Records (MBR) for routine cleaning and process activities, including automation recipe updates.
• QA review and approval of SOPs, Work Instructions, and forms from other departments.
• Attend daily/weekly Operations-led team meetings.
• Conduct Gemba walkdowns and Inspection Readiness walkdowns from a QA perspective.
• QA review and approval of Warehouse Shipping Picklists.
• Act as the primary QA point of contact for Quarantine Shipments.
• Responsible for Batch Book filing and archival.
• QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
• Initiate and own QA non-conformance records.
• Perform periodic reviews of Quality Assurance and Quality Systems SOPs.
• Act as the primary Quality representative at Root Cause Analysis meetings.
• Serve as the primary QA point of contact for the Returns process.

Minimum RequirementsKey Skills and Competencies

• Builds strong, productive relationships.
• Demonstrates the ability to work effectively with teams and individuals.
• Seeks opportunities for professional growth and development.
• Utilises best practices to improve business operations.
• Holds themselves accountable for compliant and flawless execution.
• Takes responsibility for decisions that build customer value.
• Effectively manages and adapts to change.
• Always demonstrates integrity and Credo-based actions.
• Able to work independently, manage time effectively, and meet deadlines.

Education and Experience

• Third-level degree in a science or pharmaceutical discipline.
• Minimum of 3-5 years’ experience in the pharmaceutical industry.
• Working knowledge of quality processes and systems is desirable.
• Demonstrated knowledge and application of industry regulations, including FDA, HPRA, EMEA and other authorities.